PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.
The main questions PLATIPUS aims to answer are:
1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)
2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains).
This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

开始日期2025-11-01

申办/合作机构

University of Melbourne

[+10]

NCT07063082

/ Not yet recruitingN/AIIT

Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis

The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis.

开始日期2025-07-07

申办/合作机构

Cairo University

NCT06574204

/ Not yet recruitingN/AIIT

The Mechanism and Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Resulting From Macrolides

Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.

开始日期2024-09-01

申办/合作机构

南通大学附属医院

100 项与硬脂酸红霉素相关的临床结果

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100 项与硬脂酸红霉素相关的转化医学

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100 项与硬脂酸红霉素相关的专利（医药）

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22,844

项与硬脂酸红霉素相关的文献（医药）

2026-03-16·SPECTROSCOPY LETTERS

Ecological and human health risk assessment of pharmaceutical compounds in the Indian river ecosystem

作者: Ruby, Ruby ; Giri, Arup ; Dimple, Dimple ; Jyoti, Jyoti

Pharmaceutical compounds release into aquatic ecosystem has become a critical problem because they can harm aquatic organisms and humans. Humans may have serious effects due to presence of phamaceuticals in drinking water.This study aims to analyze pharmaceutical compound ecol. and human health risk assessments in thirteen Indian River ecosystems. In this study, various pharmaceuticals, such as ciprofloxacin, norfloxacin, aspirin, carbamazepine, caffeine, and ibuprofen, were detected in different river ecosystems across India. This study aims to analyze the concentrations of pharmaceutical compounds, including the risk quotient (RQ), while performing an ecol. risk assessment.For human health risk assessment, metrics such as acceptable daily intake (ADI) and the risk quotient were employed to assess human health (RQH). The health risk models revealed that the Sirsa River posed significant ecol. threats because RQ greater than 1, whereas the other rivers presented moderate risks. Children were found to be more vulnerable to pharmaceutical intake, and all the rivers presented RQH values exceeding 1 for adults, underscoring serious health concerns.This study will help categorize pharmaceutical compounds and analyze the ecol. and human health risks to water systems. This study provides key insights for policymakers and public health efforts to address pharmaceutical pollution in Indian rivers. It also aligns with the UN Sustainable Development Goals, particularly SDGs 6 and 12.

2026-01-17·NATURAL PRODUCT RESEARCH

Chemical constituents and antimicrobial activity of the aerial part of Solanum betaceum Cav. (Solanaceae)

Article

作者: Barboni, Luciano ; Kianfé, Boris Yotta ; Teponno, Rémy Bertrand ; Tsopmene, Ulrich Joël ; Dzoyem, Jean Paul ; Ponou, Beaudelaire Kemvoufo ; Tapondjou, Léon Azefack ; Demgne, Léannick Wandji

A new saponin namely diosgeninoside (25 R-spirost-5-en-3-O-[β-_D-glucopyranosyl (1→2) - β-_D-glucuronic acid]) and a new fatty acid betacic acid: (Z)-8(S*),9(S*),10(R*)-trihydroxy-11-octadecenoic acid together with six known compounds: N-trans-coumaroyl tyramine, ergosta-7,22-dien-3β,5α,6β-triol, β-sitosterol, and β-sitosterol-3-O-β-_D-glucopyranoside, L-threitol and soya-cerebroside I were isolated from the methanolic extract of Solanum betaceum. The structures were elucidated by interpretation of their 1D and 2D NMR spectra and spectrometric data. The methanolic extract, the EtOAc and n-BuOH fractions, and several isolated compounds were tested for antibacterial activity against four bacteria (Staphylococcus aureus; Staphylococcus epidermidis; Escherichia coli; and Pseudomonas aeruginosa). The methanolic extract and the EtOAc fraction showed moderate activity against Staphylococcus aureus and Pseudomonas aeruginosa with MIC value of 128 µg/mL. Compound 1 showed moderate activity against Staphylococcus aureus with MIC value of 64 µg/mL.

2025-12-31·Emerging Microbes & Infections

Genomic islands and molecular mechanisms relating to drug-resistance in Clostridioides ( Clostridium ) difficile PCR ribotype 176

Article

作者: Novakova Elena ; Pituch Hanna ; Brajerova Marie ; Smits Wiep Klaas ; Demay Fanny ; Kuijper Ed ; Krutova Marcela ; Balikova Novotna Gabriela ; Prasad Suhanya ; Soltesova Anna ; Zikova Jaroslava ; Kovarovic Vojtech

OBJECTIVES:

To analyse characteristics of Clostridioides difficile PCR ribotype 176 clinical isolates from Poland, the Czech Republic and Slovakia with regard to the differences in its epidemiology.

METHODS:

Antimicrobial susceptibility testing and whole genome sequencing were performed on a selected group of 22 clonally related isolates as determined by multilocus variable-number tandem repeat analysis (n = 509). Heterologous expression and functional analysis of the newly identified methyltransferase were performed.

RESULTS:

Core genome multilocus sequence typing found 10-37 allele differences. All isolates were resistant to fluoroquinolones (gyrA_p. T82I), aminoglycosides with aac(6')-Ie-aph(2'')-Ia in six isolates. Erythromycin resistance was detected in 21/22 isolates and 15 were also resistant to clindamycin with ermB gene. Fourteen isolates were resistant to rifampicin with rpoB_p. R505K or p. R505K/H502N, and five to imipenem with pbp1_p. P491L and pbp3_p. N537K. PnimB^G together with nimB_p. L155I were detected in all isolates but only five were resistant to metronidazole on chocolate agar. The cfrE, vanZ1 and cat-like genes were not associated with linezolid, teicoplanin and chloramphenicol resistance, respectively. The genome comparison identified six transposons carrying antimicrobial resistance genes. The ermB gene was carried by new Tn7808, Tn6189 and Tn6218-like. The aac(6')-Ie-aph(2'')-Ia were carried by Tn6218-like and new Tn7806 together with cfrE gene. New Tn7807 carried a cat-like gene. Tn6110 and new Tn7806 contained an RlmN-type 23S rRNA methyltransferase, designated MrmA, associated with high-level macrolide resistance in isolates without ermB gene.

CONCLUSIONS:

Multidrug-resistant C. difficile PCR ribotype 176 isolates carry already described and unique transposons. A novel mechanism for erythromycin resistance in C. difficile was identified.

项与硬脂酸红霉素相关的新闻（医药）

2026-06-22

·Pharm-Patent

Zasocitinib研究进展（V1,2026.6.22更新）

1、研究机构：武田药品工业株式会社、Nimbus Lakshmi、武田（中国）国际贸易有限公司、Nimbus Therapeutics、Schrödinger 2、别名：NDI-034858、TAK-279、扎索替尼 3、靶点：TYK24、剂型及给药途径：普通胶囊剂; 口服给药；普通片剂; 口服给药 5、结构式 6、适应症及进展适应症进展最新进展日期斑块状银屑病 III期 2026-06-11 红皮病型银屑病、泛发性脓疱型银屑病 III期 2025-09-10 银屑病关节炎 III期 2026-05-12 非节段型白癜风 II期 2026-05-18 化脓性汗腺炎 II期 2026-03-20 克罗恩病 II期 2026-02-11 溃疡性结肠炎 II期 2026-05-07 7、发表论文标题内容类型适应症企业技术平台来源发表日期 zasocitinib (tak-279), an investigational oral, allosteric, highly selective and potent tyk2 inhibitor preserves anti-inflammatory il-10 signaling in vitro 药理研究炎症性肠病武田药品工业株式会社 2026 DDW 2026-05-02 In Vitro Pharmacological Profile of GLPG3667 Suggests Differentiation from the TYK2 Inhibitors Deucravacitinib and Zasocitinib at their Clinical Dose Regimens 药理研究自身免疫性疾病 Lakefront Biotherapeutics 2025 ACR 2025-10-26 zasocitinib (tak-279) exhibits high levels of tyk2 inhibition and no inhibition of jak 1/3 when compared with licensed tyk2 and jak inhibitors 药理研究炎症武田药品工业株式会社 2025 EULAR 2025-06-11 Zasocitinib (TAK-279) Displays High Levels of TYK2 Inhibition and No Inhibition of JAK 1/3 Compared with Licensed TYK2 and JAK Inhibitors 药理研究银屑病关节炎武田药品工业株式会社 2024 ACR 2024-11-17 Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279 药物发现银屑病关节炎 Nimbus Therapeutics Schrödinger Piramal Pharma J Med Chem IF=6.8 2023-07-10 8、交易交易名称交易类型转让方受让方交易时研发状态权益类型权益地区权益适应症交易金额交易时间 Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary收购完成转让/收购 Nimbus Lakshmi 武田药品工业株式会社临床II期开发/商业化权首付款：4000百万美元里程碑付款：2000百万美元 2023-02-08 Takeda to Acquire 100% Ownership of Nimbus Therapeutics’TYK2 Program Subsidiary 转让/收购 Nimbus Lakshmi 武田药品工业株式会社临床II期开发/商业化权首付款：4000百万美元里程碑付款：2000百万美元 2022-12-13 9、专利布局公开（公告）号专利主题发明名称申请日法律状态 CN111194317A 化合物 Tyk2抑制剂与其用途 2018-07-26 实质审查 CN117946114A 化合物 Tyk2抑制剂与其用途 2018-07-26 实质审查 CN117946115A 化合物 Tyk2抑制剂与其用途 2018-07-26 实质审查 CN121991078A 化合物 Tyk2抑制剂与其用途 2018-07-26 实质审查 US10508120B2 化合物 TYK2抑制剂及其用途 2019-04-12 CN118922420A 制备工艺 TYK2抑制剂合成及其中间体 2023-03-24 实质审查 CN118973583A 用途 TYK2抑制剂及其用途 2023-03-24 实质审查 CN118974052A 晶型 TYK2抑制剂的固体形式和使用方法 2023-03-24 实质审查 CN118922192A 制剂 TYK2抑制剂制剂及其制备方法 2023-03-24 实质审查 CN122003239A 用途用于治疗炎症性肠病的TYK2抑制剂 2024-09-20 实质审查 10、研究历程 2026年06月15日，由武田药品工业株式会社开展临床二期试验，用于治疗克罗恩病。（NCT07403968） 2026年05月11日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在比利时、保加利亚和智利等国家和地区开展临床三期试验，用于治疗银屑病关节炎。（CTR20261486） 2026年03月20日，由Takeda Development Center Americas Inc、Serán BioScience LLC和武田（中国）国际贸易有限公司在澳大利亚、加拿大和法国等国家和地区开展临床二期试验，用于治疗化脓性汗腺炎。（CTR20261070） 2026年01月26日，由武田药品工业株式会社在澳大利亚、加拿大和法国等国家和地区开展临床二期试验，用于治疗化脓性汗腺炎。（NCT07244263） 2025年11月03日，由武田药品工业株式会社在加拿大、法国和意大利等国家和地区开展临床二期试验，用于治疗白癜风。（NCT07108283） 2025年09月08日，由Takeda Development Center Americas Inc、Serán BioScience LLC和武田（中国）国际贸易有限公司在中国台湾和中国大陆开展临床二期试验，用于治疗溃疡性结肠炎和克罗恩病。（CTR20253088; CTR20253581） 2025年06月20日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床三期试验，用于治疗银屑病关节炎。（CTR20251181; CTR20261486） 2025年05月28日，由Takeda Development Center Americas Inc、武田药品工业株式会社、Serán BioScience LLC和武田（中国）国际贸易有限公司在澳大利亚、比利时和保加利亚等国家和地区开展临床二期试验，用于治疗溃疡性结肠炎和克罗恩病。（CTR20253581; NCT06764615） 2025年04月10日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在阿根廷、澳大利亚和巴西等国家和地区开展临床三期试验，用于治疗银屑病关节炎。（CTR20251181; CTR20261486） 2025年04月03日，由Takeda Development Center Americas Inc在中国大陆开展临床一期试验，用于治疗溃疡性结肠炎。（JXHL2500004） 2025年03月10日，由武田药品工业株式会社在阿根廷、澳大利亚和巴西等国家和地区开展临床三期试验，用于治疗银屑病关节炎。（NCT07286058; NCT06671496） 2025年03月03日，由武田药品工业株式会社在比利时、保加利亚和智利等国家和地区开展临床三期试验，用于治疗银屑病关节炎。（NCT07286058; NCT06671483; NCT06671496） 2025年02月27日，由Takeda Development Center Americas Inc在中国大陆开展临床一期试验，用于治疗银屑病关节炎。（JXHL2500012; JXHL2500011） 2025年01月17日，由Takeda Development Center Americas Inc向中国国家药品监督管理局NMPA提交IND申请，用于治疗银屑病关节炎。（JXHL2500012; JXHL2500011） 2025年01月08日，由Takeda Development Center Americas Inc向中国国家药品监督管理局NMPA提交IND申请，用于治疗溃疡性结肠炎。（JXHL2500004） 2024年09月25日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床二期试验，用于治疗克罗恩病。（CTR20253581; CTR20242633） 2024年09月11日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在阿根廷、保加利亚和法国等国家和地区开展临床三期试验，用于治疗斑块银屑病。（CTR20260706; CTR20251323） 2024年06月30日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床一期试验。（CTR20241262） 2024年06月24日，由武田药品工业株式会社在中国大陆开展临床一期试验。（NCT06111547） 2024年06月18日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国台湾开展临床三期试验，用于治疗斑块银屑病。（CTR20241646; CTR20251323） 2024年06月17日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床三期试验，用于治疗斑块银屑病。（CTR20241646; CTR20260706; CTR20241652; CTR20251323） 2024年06月04日，由Takeda Development Center Americas Inc、Serán BioScience LLC和武田（中国）国际贸易有限公司在澳大利亚、比利时和保加利亚等国家和地区开展临床二期试验，用于治疗溃疡性结肠炎。（CTR20253088; CTR20253581） 2024年03月29日，由武田药品工业株式会社在澳大利亚、比利时和保加利亚等国家和地区开展临床二期试验，用于治疗溃疡性结肠炎。（NCT06254950; NCT06764615） 2024年03月29日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床一期试验，用于治疗克罗恩病。（JXHL2400004; JXHL2400003） 2024年03月28日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在比利时、加拿大和丹麦等国家和地区开展临床二期试验，用于治疗克罗恩病。（CTR20253581; CTR20242633） 2024年03月19日，由武田药品工业株式会社在日本开展临床三期试验，用于治疗红皮病型银屑病和泛发性脓疱型银屑病。（NCT06323356） 2024年03月05日，由武田药品工业株式会社在澳大利亚、比利时和巴西等国家和地区开展临床二期试验，用于治疗克罗恩病。（NCT06764615; NCT06233461） 2024年01月06日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗克罗恩病。（JXHL2400004; JXHL2400003） 2024年01月02日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在中国大陆开展临床一期试验，用于治疗斑块银屑病。（JXHL2300262） 2023年11月13日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司在澳大利亚、加拿大和德国等国家和地区开展临床三期试验，用于治疗斑块银屑病。（CTR20241646; CTR20260706; CTR20251323） 2023年11月06日，由武田药品工业株式会社在阿根廷、澳大利亚和保加利亚等国家和地区开展临床三期试验，用于治疗斑块银屑病。（NCT06108544; NCT06550076; NCT06088043; NCT07250802; NCT06973291） 2023年10月20日，由Takeda Development Center Americas Inc和武田（中国）国际贸易有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗斑块银屑病。（JXHL2300262） 2023年08月11日，由武田药品工业株式会社在美国开展临床一期试验。（NCT06793943; NCT06290050; NCT05995249; NCT06258265; NCT05992155） 2022年12月13日，由武田药品工业株式会社开展临床二期试验，用于治疗银屑病。（https://assets-dam.takeda.com/raw/upload/legacy-dotcom/siteassets/system/what-we-do/research-and-development-rd-in-takeda/our-pipeline/qr2022_q4_development-pipeline-by-phase_en.pdf） 2022年01月06日，由Nimbus Lakshmi Inc和武田药品工业株式会社在德国、波兰和美国等国家和地区开展临床二期试验，用于治疗银屑病关节炎。（NCT05153148） 2021年08月11日，由Nimbus Lakshmi Inc和武田药品工业株式会社在加拿大和美国开展临床二期试验，用于治疗斑块银屑病。（NCT04999839） 2017年10月03日，由新基公司开展临床前研究试验。（https://www.nimbustx.com/2017/10/03/nimbus-therapeutics-and-celgene-enter-long-term-strategic-immunology-alliance-to-develop-programs-for-patients-with-autoimmune-disorders/） 11、临床试验登记号试验标题试验药适应症原始适应症申办/合作机构试验状态试验分期开始日期完成日期国家/地区 ChiCTR2600121697 A Phase 1, Randomized, Double-blinded, Placebo-Controlled, Single and Multiple Oral Doses Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of TAK-279 in Healthy Chinese Subjects 扎索替尼 - None 复旦大学附属华山医院 Completed 临床1期 2024-03-06 2025-03-30 中国 NCT07403968 An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease 扎索替尼 (口服) 克罗恩病 Crohn's Disease Takeda Pharmaceutical Co., Ltd. Not yet recruiting 临床2期 2026-06-15 2028-03-30 - NCT07286058 A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs 扎索替尼 (口服凝胶剂, 口服) 银屑病关节炎 Psoriatic Arthritis Takeda Pharmaceutical Co., Ltd. Recruiting 临床3期 2026-03-11 2029-12-18 美国 | 日本 NCT07250802 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis 扎索替尼斑块状银屑病 Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. Recruiting 临床3期 2025-12-04 2033-01-24 美国 | 日本 | 中国 | 波兰 | 意大利 | 德国 | 西班牙 NCT07244263 A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa 扎索替尼化脓性汗腺炎 Hidradenitis Suppurativa Takeda Pharmaceutical Co., Ltd. Recruiting 临床2期 2026-01-26 2028-02-22 加拿大 | 荷兰 | 美国 | 中国 | 波兰 | 法国 | 澳大利亚 | 德国 NCT07108283 A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants With Nonsegmental Vitiligo 扎索替尼 (胶囊剂) 非节段型白癜风 Nonsegmental Vitiligo Takeda Pharmaceutical Co., Ltd. Recruiting 临床2期 2025-11-03 2027-11-09 加拿大 | 美国 | 日本 | 中国 | 波兰 | 墨西哥 | 意大利 | 法国 | 西班牙 NCT06973291 A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis 扎索替尼 (片剂) 斑块状银屑病 Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. Completed 临床3期 2025-07-09 2026-04-22 加拿大 | 拉脱维亚 | 捷克 | 美国 | 日本 | 波兰 | 法国 | 保加利亚 NCT06793943 A Phase 1, Open-Label, 4-Part Trial to Assess the Drug-Drug Interaction Between Zasocitinib and Combined Oral Contraceptives, a MATE Substrate, a P-gp Substrate, and a Proton-Pump Inhibitor in Healthy Participants 扎索替尼 (片剂) | 地高辛 (片剂) | 盐酸二甲双胍 (片剂) | 埃索美拉唑镁 (胶囊剂) - Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2025-01-23 2025-03-30 美国 NCT06764615 A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease 扎索替尼 (胶囊剂, 口服) 克罗恩病 | 溃疡性结肠炎 Crohn's Disease | Ulcerative Colitis Takeda Pharmaceutical Co., Ltd. Recruiting 临床2期 2025-05-28 2029-12-30 韩国 | 荷兰 | 匈牙利 | 捷克 | 美国 | 中国 | 波兰 | 斯洛伐克 NCT06671496 A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002) 扎索替尼 (片剂) 银屑病关节炎 Psoriatic Arthritis Takeda Pharmaceutical Co., Ltd. Recruiting 临床3期 2025-03-10 2028-01-26 加拿大 | 阿根廷 | 美国 | 日本 | 中国 | 波兰 | 巴西 | 英国 | 法国 | 澳大利亚 | 德国 | 西班牙 NCT06671483 A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001) 扎索替尼 (包衣微粒片) 银屑病关节炎 Psoriatic Arthritis Takeda Pharmaceutical Co., Ltd. Recruiting 临床3期 2025-03-03 2028-01-28 美国 | 匈牙利 | 捷克 | 葡萄牙 | 西班牙 | 新西兰 | 韩国 | 拉脱维亚 | 比利时 | 中国台湾 | 波兰 | 墨西哥 | 意大利 | 以色列 | 智利 | 保加利亚 | 德国 | 爱沙尼亚 | 克罗地亚 NCT06550076 A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis 扎索替尼 (片剂, 口服) 斑块状银屑病 Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. Active, not recruiting 临床3期 2024-09-04 2029-08-05 美国 | 阿根廷 | 匈牙利 | 捷克 | 日本 | 英国 | 西班牙 | 加拿大 | 韩国 | 拉脱维亚 | 中国 | 中国台湾 | 波兰 | 意大利 | 以色列 | 法国 | 保加利亚 | 澳大利亚 | 德国 NCT06323356 A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Adult Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis 扎索替尼泛发性脓疱型银屑病 | 红皮病性银屑病 Generalized Pustular Psoriasis | Erythrodermic Psoriasis Takeda Pharmaceutical Co., Ltd. Active, not recruiting 临床3期 2024-03-19 2026-07-22 日本 NCT06290050 A Phase 1, Open-Label, Drug-Drug Interaction Study to Assess the Effect of TAK-279 on the Pharmacokinetics of a Sensitive CYP3A4 Substrate and a Sensitive CYP2C8 Substrate in Healthy Subjects 扎索替尼 (胶囊剂) | 瑞格列奈 (片剂) | 咪达唑仑 (糖浆剂) - Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2024-03-29 2024-05-16 美国 NCT06258265 A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Design Thorough QT Study With Nested Crossover to Investigate the Potential of TAK-279 to Prolong the QTc Interval in Adult Healthy Subjects 扎索替尼 (胶囊剂) | 盐酸莫西沙星 (包衣片) - Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2024-04-29 2024-07-09 美国 NCT06254950 A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis 扎索替尼 (胶囊剂, 口服) 炎症 | 溃疡性结肠炎 Ulcerative Colitis Takeda Pharmaceutical Co., Ltd. Active, not recruiting 临床2期 2024-03-29 2027-08-04 罗马尼亚 | 匈牙利 | 捷克 | 美国 | 日本 | 英国 | 希腊 | 加拿大 | 韩国 | 比利时 | 挪威 | 中国 | 中国台湾 | 波兰 | 丹麦 | 意大利 | 斯洛伐克 | 以色列 | 法国 | 保加利亚 | 澳大利亚 | 德国 NCT06233461 A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease 扎索替尼 (胶囊剂, 口服) 炎症 | 克罗恩病 Crohn's Disease Takeda Pharmaceutical Co., Ltd. Recruiting 临床2期 2024-03-05 2027-07-23 罗马尼亚 | 匈牙利 | 捷克 | 美国 | 日本 | 英国 | 瑞士 | 希腊 | 加拿大 | 韩国 | 荷兰 | 比利时 | 挪威 | 中国 | 中国台湾 | 波兰 | 丹麦 | 巴西 | 意大利 | 斯洛伐克 | 以色列 | 法国 | 保加利亚 | 澳大利亚 | 德国 NCT06111547 A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Oral Doses Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of TAK-279 in Healthy Chinese Subjects 扎索替尼 (片剂, 口服) - Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2024-06-24 2024-08-04 中国 NCT06108544 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis 扎索替尼斑块状银屑病 Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. Completed 临床3期 2023-11-06 2025-11-07 美国 | 阿根廷 | 匈牙利 | 捷克 | 英国 | 西班牙 | 希腊 | 加拿大 | 拉脱维亚 | 中国 | 波兰 | 以色列 | 法国 | 保加利亚 | 德国 NCT06088043 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis 扎索替尼斑块状银屑病 Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. Completed 临床3期 2023-11-06 2025-10-22 加拿大 | 韩国 | 美国 | 日本 | 中国 | 中国台湾 | 波兰 | 意大利 | 澳大利亚 | 德国 NCT05995249 A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects 硬脂酸红霉素 (片剂) | 扎索替尼 (胶囊剂) | 依非韦伦 (片剂) | 苯妥英 (胶囊剂) - Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2023-08-11 2023-12-31 美国 NCT05992155 An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Renal Impairment 扎索替尼 (胶囊剂, 口服) 肾脏疾病 | 肾功能不全 Renal Impairment | Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2023-09-27 2024-05-28 美国 NCT05976321 An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Hepatic Impairment 扎索替尼 (胶囊剂, 口服) 肝功能不全 | 肝损伤 Hepatic Impairment | Healthy Volunteers Takeda Pharmaceutical Co., Ltd. Completed 临床1期 2023-09-22 2024-04-15 美国 NCT05153148 A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis 扎索替尼 (胶囊剂, 口服) 银屑病关节炎 Psoriatic Arthritis Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. Completed 临床2期 2022-01-06 2023-06-02 捷克 | 美国 | 波兰 | 德国 NCT04999839 A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis 扎索替尼 (口服滴剂, 口服) 斑块状银屑病 Moderate to Severe Plaque Psoriasis Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. Completed 临床2期 2021-08-11 2022-09-12 加拿大 | 美国 12、临床结果标题登记号来源分期适应症评价人数用药方案结果评价发布日期申办/合作机构主要研究药物来源链接 Synapse链接 Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial NCT04999839 Pubmed 临床2期斑块状银屑病 151 Zasocitinib 30 mg PASI100(12-week) = 30.0 % 积极 2026-05-16 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://pubmed.ncbi.nlm.nih.gov/42143206/ | https://doi.org/10.1007/s13555-026-01738-6 https://synapse.zhihuiya.com/clinical-result-detail/52ad5484e24eae525a454a5a2ae2204e Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial NCT04999839 Pubmed 临床2期斑块状银屑病 151 Placebo PGA 1(12-week) = 10.0 % 积极 2026-05-16 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://pubmed.ncbi.nlm.nih.gov/42143206/ | https://doi.org/10.1007/s13555-026-01738-6 https://synapse.zhihuiya.com/clinical-result-detail/52ad5484e24eae525a454a5a2ae2204e Early onset of response to zasocitinib (TAK-279), a highly selective and potent TYK2 inhibitor, is correlated with modulation of TYK2 signaling and disease pathway biomarkers in patients with moderate-to-severe plaque psoriasis NCT04999839 AAD 临床2期斑块状银屑病 62 Zasocitinib 15mg QD Early response(clinical) = 2.0 Week 积极 2026-03-27 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://eposters.aad.org/abstracts/74503 https://synapse.zhihuiya.com/clinical-result-detail/a48388259aaa253522205e2a8822903e MODULATION OF SOLUBLE BIOMARKERS OF CARTILAGE AND BONE TURNOVER AND INFLAMMATION BY ZASOCITINIB (TAK-279), AN ORAL, ALLOSTERIC, HIGHLY SELECTIVE AND POTENT TYK2 INHIBITOR, IS ASSOCIATED WITH CLINICAL RESPONSE IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS NCT05153148 EULAR 临床2期银屑病关节炎 290 Zasocitinib 15 mg ACR20 = Among ACR20 responders, zasocitinib-treated patients generally exhibited dose-dependent reductions from baseline in IL-6, VEGF-A, CCL8 and TWEAK at both Weeks 4 and 12. Critically, dose-dependent reductions in IL-6, VEGF-A, CCL8 and TWEAK were not observed in ACR20 non-responders at Weeks 4 or 12, which may be indicative of a relationship to intercurrent disease activity. Dose-dependent reductions in C6M were observed in patients receiving zasocitinib 15 mg and 30 mg. 积极 2025-06-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2025POS1344 https://synapse.zhihuiya.com/clinical-result-detail/3825a35a9e5ea34a259ea95e22a53aee MODULATION OF SOLUBLE BIOMARKERS OF CARTILAGE AND BONE TURNOVER AND INFLAMMATION BY ZASOCITINIB (TAK-279), AN ORAL, ALLOSTERIC, HIGHLY SELECTIVE AND POTENT TYK2 INHIBITOR, IS ASSOCIATED WITH CLINICAL RESPONSE IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS NCT05153148 EULAR 临床2期银屑病关节炎 290 Zasocitinib 30 mg ACR20 = Among ACR20 responders, zasocitinib-treated patients generally exhibited dose-dependent reductions from baseline in IL-6, VEGF-A, CCL8 and TWEAK at both Weeks 4 and 12. Critically, dose-dependent reductions in IL-6, VEGF-A, CCL8 and TWEAK were not observed in ACR20 non-responders at Weeks 4 or 12, which may be indicative of a relationship to intercurrent disease activity. Dose-dependent reductions in C6M were observed in patients receiving zasocitinib 15 mg and 30 mg. 积极 2025-06-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2025POS1344 https://synapse.zhihuiya.com/clinical-result-detail/3825a35a9e5ea34a259ea95e22a53aee ZASOCITINIB (TAK-279), A HIGHLY SELECTIVE ORAL TYROSINE KINASE 2 (TYK2) INHIBITOR, ELICITS MINIMAL DISEASE ACTIVITY AND EARLY SKIN RESPONSES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMISED PHASE 2B STUDY NCT05153148 EULAR 临床2期银屑病关节炎 290 ZASOCITINIB 15mg ACR20(Week 12) = 53.3 % 积极 2025-06-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2025POS0107 https://synapse.zhihuiya.com/clinical-result-detail/a32228eeaa9e82deaa92d852283a5d5a ZASOCITINIB (TAK-279), A HIGHLY SELECTIVE ORAL TYROSINE KINASE 2 (TYK2) INHIBITOR, ELICITS MINIMAL DISEASE ACTIVITY AND EARLY SKIN RESPONSES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMISED PHASE 2B STUDY NCT05153148 EULAR 临床2期银屑病关节炎 290 ZASOCITINIB 30mg ACR20(Week 12) = 54.2 % 积极 2025-06-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://scientific.sparx-ip.net/archiveeular/?c=a&view=2&item=2025POS0107 https://synapse.zhihuiya.com/clinical-result-detail/a32228eeaa9e82deaa92d852283a5d5a Influence of Patient Baseline Characteristics on Zasocitinib (TAK-279) Efficacy, a Selective Oral Tyrosine Kinase 2 Inhibitor: A Randomized Phase 2b Trial in Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 15 mg ACR20(Week 12) = 53.3 % 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/influence-of-patient-baseline-characteristics-on-zasocitinib-tak-279-efficacy-a-selective-oral-tyrosine-kinase-2-inhibitor-a-randomized-phase-2b-trial-in-psoriatic-arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/295ea8825a4840e232822425534e24ed Influence of Patient Baseline Characteristics on Zasocitinib (TAK-279) Efficacy, a Selective Oral Tyrosine Kinase 2 Inhibitor: A Randomized Phase 2b Trial in Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 30 mg ACR20(Week 12) = 54.2 % 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/influence-of-patient-baseline-characteristics-on-zasocitinib-tak-279-efficacy-a-selective-oral-tyrosine-kinase-2-inhibitor-a-randomized-phase-2b-trial-in-psoriatic-arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/295ea8825a4840e232822425534e24ed Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 15 mg MDA(Week 12) = 28.0 % 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/zasocitinib-tak-279-a-highly-selective-oral-tyrosine-kinase-2-tyk2-inhibitor-elicits-early-skin-responses-and-minimal-disease-activity-in-patients-with-active-psoriatic-arthritis-results-from-a/ https://synapse.zhihuiya.com/clinical-result-detail/28e295a4952ea8e8a025885ea255ea5a Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 30 mg MDA(Week 12) = 29.2 % 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/zasocitinib-tak-279-a-highly-selective-oral-tyrosine-kinase-2-tyk2-inhibitor-elicits-early-skin-responses-and-minimal-disease-activity-in-patients-with-active-psoriatic-arthritis-results-from-a/ https://synapse.zhihuiya.com/clinical-result-detail/28e295a4952ea8e8a025885ea255ea5a Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 15 mg - 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/zasocitinib-tak-279-an-oral-selective-tyrosine-kinase-2-inhibitor-achievement-of-remission-and-additional-improvements-in-disease-activity-in-patients-with-psoriatic-arthritis-enrolled-in-a-phase/ https://synapse.zhihuiya.com/clinical-result-detail/2824e83de098e33ae3a35ae293920a28 Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 30 mg - 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/zasocitinib-tak-279-an-oral-selective-tyrosine-kinase-2-inhibitor-achievement-of-remission-and-additional-improvements-in-disease-activity-in-patients-with-psoriatic-arthritis-enrolled-in-a-phase/ https://synapse.zhihuiya.com/clinical-result-detail/2824e83de098e33ae3a35ae293920a28 Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 Placebo 三酸甘油脂(CTCAE Grade 3 elevations) = 4.0 Pts 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/assessment-of-laboratory-parameter-changes-in-a-phase-2b-trial-of-zasocitinib-tak-279-an-oral-highly-selective-tyk2-inhibitor-in-patients-with-active-psoriatic-arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/25599ad0e980d2835e223e8a25833925 Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 Zasocitinib 5mg 淋巴细胞减少(CTCAE Grade 2) = 4.0 Pts 积极 2024-11-10 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/assessment-of-laboratory-parameter-changes-in-a-phase-2b-trial-of-zasocitinib-tak-279-an-oral-highly-selective-tyk2-inhibitor-in-patients-with-active-psoriatic-arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/25599ad0e980d2835e223e8a25833925 Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial NCT04999839 Pubmed 临床2期斑块状银屑病 259 Zasocitinib 2 mg PASI75(12-week) = 18 % 积极 2024-10-01 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://pubmed.ncbi.nlm.nih.gov/39167366/ | https://doi.org/10.1001/jamadermatol.2024.2701 https://synapse.zhihuiya.com/clinical-result-detail/22e825838d35229e50d4aea2882e0a8a Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial NCT04999839 Pubmed 临床2期斑块状银屑病 259 Zasocitinib 5 mg PASI75(12-week) = 44 % 积极 2024-10-01 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://pubmed.ncbi.nlm.nih.gov/39167366/ | https://doi.org/10.1001/jamadermatol.2024.2701 https://synapse.zhihuiya.com/clinical-result-detail/22e825838d35229e50d4aea2882e0a8a A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis NCT05153148 CTgov 临床2期银屑病关节炎 305 Placebo(Placebo) Percentage of Participants Who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12 = 29.2 % (95%CI, 18.7 ~ 39.7) - 2024-05-31 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://clinicaltrials.gov/ct2/show/results/NCT05153148 https://synapse.zhihuiya.com/clinical-result-detail/d5e555a4ae25aa38089022aae92e204a A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis NCT05153148 CTgov 临床2期银屑病关节炎 305 NDI-034858(NDI-034858 Low Dose) Percentage of Participants Who Achieved at Least an American College of Rheumatology 20 (ACR20) Response at Week 12 = 35.2 % (95%CI, 24.1 ~ 46.3) - 2024-05-31 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://clinicaltrials.gov/ct2/show/results/NCT05153148 https://synapse.zhihuiya.com/clinical-result-detail/d5e555a4ae25aa38089022aae92e204a Clinical efficacy of TAK-279, a highly selective oral tyrosine kinase 2 (TYK2) inhibitor, is associated with modulation of disease and TYK2 pathway biomarkers in patients with moderate-to-severe psoriasis NCT04999839 AAD 临床2期银屑病 44 TAK-279 2mg IL-17A(Week 12; in most histologic responders (>80% versus baseline lesion levels)) = 18.0 Pts 积极 2024-03-08 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://eposters.aad.org/archives/AM2024/50378 https://synapse.zhihuiya.com/clinical-result-detail/2238425222ad08e54242880a20255358 Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 TAK-279 5TAK-279 5TAK-279 5 mg ACR20(12 Week) = 35.2 % 积极 2023-10-24 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/efficacy-and-safety-outcomes-of-tak-279-a-selective-oral-tyrosine-kinase-2-tyk2-inhibitor-from-a-randomized-double-blind-placebo-controlled-phase-2b-trial-in-patients-with-active-psoriatic-arthr/ https://synapse.zhihuiya.com/clinical-result-detail/295a8ade32aa92de55adaa408a232859 Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis NCT05153148 ACR 临床2期银屑病关节炎 290 TAK-279 15 mg ACR20(12 Week) = 53.3 % 积极 2023-10-24 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://acrabstracts.org/abstract/efficacy-and-safety-outcomes-of-tak-279-a-selective-oral-tyrosine-kinase-2-tyk2-inhibitor-from-a-randomized-double-blind-placebo-controlled-phase-2b-trial-in-patients-with-active-psoriatic-arthr/ https://synapse.zhihuiya.com/clinical-result-detail/295a8ade32aa92de55adaa408a232859 Patient-reported outcomes in the randomized, double-blind, placebo-controlled phase 2b trial of the oral TYK2 inhibitor TAK-279 in moderate-to-severe psoriasis NCT04999839 EADV 临床2期银屑病 259 TAK-279 2 mg DLQI = decreased Point 积极 2023-10-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Psoriasis.pdf https://synapse.zhihuiya.com/clinical-result-detail/e8d2ea32922e5a20338854e5d2aa5a98 Patient-reported outcomes in the randomized, double-blind, placebo-controlled phase 2b trial of the oral TYK2 inhibitor TAK-279 in moderate-to-severe psoriasis NCT04999839 EADV 临床2期银屑病 259 TAK-279 5 mg DLQI = decreased Point 积极 2023-10-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Psoriasis.pdf https://synapse.zhihuiya.com/clinical-result-detail/e8d2ea32922e5a20338854e5d2aa5a98 A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis NCT04999839 CTgov 临床2期斑块状银屑病 259 Placebo(Placebo) Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 = 5.8 % - 2023-09-28 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://clinicaltrials.gov/ct2/show/results/NCT04999839 https://synapse.zhihuiya.com/clinical-result-detail/092aa5d29e583a259a029e25de48a582 A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis NCT04999839 CTgov 临床2期斑块状银屑病 259 NDI-034858 study drug(NDI-034858 5 mg) Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 = 44.2 % - 2023-09-28 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://clinicaltrials.gov/ct2/show/results/NCT04999839 https://synapse.zhihuiya.com/clinical-result-detail/092aa5d29e583a259a029e25de48a582 Takeda Announces Positive Topline Results from Phase 2b Study Evaluating TAK-279, a Highly Selective Oral TYK2 Inhibitor, for the Treatment of Active Psoriatic Arthritis NCT05153148 Corporate Publications 临床2期银屑病关节炎 290 TAK-279 ACR20 = The study met its primary endpoint with a greater proportion of patients treated once-daily with TAK-279 achieving at least a 20 percent improvement in signs and symptoms of disease (American College of Rheumatology 20 response) at week 12 compared to placebo. 积极 2023-09-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Announces-Positive-Topline-Results-from-Phase-2b-Study-Evaluating-TAK-279-a-Highly-Selective-Oral-TYK2-Inhibitor-for-the-Treatment-of-Active-Psoriatic-Arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/e83389543a48488e42a8542ae9e8aa09 Takeda Announces Positive Topline Results from Phase 2b Study Evaluating TAK-279, a Highly Selective Oral TYK2 Inhibitor, for the Treatment of Active Psoriatic Arthritis NCT05153148 Corporate Publications 临床2期银屑病关节炎 290 placebo ACR20 = The study met its primary endpoint with a greater proportion of patients treated once-daily with TAK-279 achieving at least a 20 percent improvement in signs and symptoms of disease (American College of Rheumatology 20 response) at week 12 compared to placebo. 积极 2023-09-11 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. 扎索替尼 https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Announces-Positive-Topline-Results-from-Phase-2b-Study-Evaluating-TAK-279-a-Highly-Selective-Oral-TYK2-Inhibitor-for-the-Treatment-of-Active-Psoriatic-Arthritis/ https://synapse.zhihuiya.com/clinical-result-detail/e83389543a48488e42a8542ae9e8aa09 Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis NCT04999839 Corporate Publications 临床2期斑块状银屑病 259 TAK-279(30mg) PASI75 = 67 % 达到积极 2023-03-18 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-positive-results-in-phase-2b-study-of-investigational-tak-279/ https://synapse.zhihuiya.com/clinical-result-detail/54a5a5a8eeea0208222de555e8a8d85e Nimbus Therapeutics Announces Positive Topline Results for Phase 2b Clinical Trial of Allosteric TYK2 Inhibitor in Psoriasis NCT04999839 Corporate Publications 临床2期银屑病 259 NDI-034858 PASI75(12 week) = statistically significant greater proportion of patients reaching PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo at 12 weeks. 积极 2022-11-30 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://www.nimbustx.com/2022/11/30/nimbus-therapeutics-announces-positive-topline-results-for-phase-2b-clinical-trial-of-allosteric-tyk2-inhibitor-in-psoriasis/ https://synapse.zhihuiya.com/clinical-result-detail/24ad95332932a420202e28da2dd2e5a8 Nimbus Therapeutics Announces Positive Topline Results for Phase 2b Clinical Trial of Allosteric TYK2 Inhibitor in Psoriasis NCT04999839 Corporate Publications 临床2期银屑病 259 Placebo PASI75(12 week) = statistically significant greater proportion of patients reaching PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) compared to placebo at 12 weeks. 积极 2022-11-30 Takeda Pharmaceutical Co., Ltd. | Nimbus Apollo, Inc. | Innovaderm Research, Inc. 扎索替尼 https://www.nimbustx.com/2022/11/30/nimbus-therapeutics-announces-positive-topline-results-for-phase-2b-clinical-trial-of-allosteric-tyk2-inhibitor-in-psoriasis/ https://synapse.zhihuiya.com/clinical-result-detail/24ad95332932a420202e28da2dd2e5a8 Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: Results from a Phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858 - Corporate Publications 临床1期银屑病 39 NDI-034858 5mg SAE = None 积极 2022-03-25 - 扎索替尼 https://www.nimbustx.com/wp-content/uploads/AAD2022-Nimbus-NDI034858-Ph1B-data.pdf https://synapse.zhihuiya.com/clinical-result-detail/a49889555a98a23500a980dd53d8a882 Analysis of histologic, molecular and clinical improvement in moderate-to-severe psoriasis: Results from a Phase 1b trial of the novel allosteric TYK2 inhibitor NDI-034858 - Corporate Publications 临床1期银屑病 39 NDI-034858 10mg SAE = None 积极 2022-03-25 - 扎索替尼 https://www.nimbustx.com/wp-content/uploads/AAD2022-Nimbus-NDI034858-Ph1B-data.pdf https://synapse.zhihuiya.com/clinical-result-detail/a49889555a98a23500a980dd53d8a882 13、转化医学研究亮点主题期刊/会议出版日期药物适应症机构 Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial **总结：** Zasocitinib（TAK-279）是一种高选择性口服TYK2抑制剂，针对中重度斑块型银屑病的IIb期试验事后分析显示其显著改善皮损清除率。该研究评估了15 mg或30 mg剂量组与安慰剂的疗效差异，包括基线特征亚组、不同身体区域及PASI评分成分（红斑、浸润、脱屑）的改善，以及患者报告的生活质量指标（如DLQI 0/1）。结果显示，治疗12周后，Zasocitinib组在几乎所有亚组中均显著优于安慰剂，PASI 75/90/100和PGA 0/1达标率更高，且各身体区域及评分成分均一致改善。疗效最早第2周显现，持续至第12周。PASI ≤1/≤2或PASI 75/90/100达标者多数同时实现DLQI 0/1，表明生活质量显著提升。PASI与PGA×BSA改善高度相关（ρ=0.95）。结论：Zasocitinib疗效不受基线特征影响，皮损清除效果全面，且能显著改善患者生活质量。试验注册号：NCT04999839。 2期临床研究 Dermatol Ther (Heidelb) 2026-05-16 扎索替尼斑块状银屑病 Takeda Pharmaceutical Co., Ltd. Early onset of response to zasocitinib (TAK-279), a highly selective and potent TYK2 inhibitor, is correlated with modulation of TYK2 signaling and disease pathway biomarkers in patients with moderate-to-severe plaque psoriasis **总结：** Zasocitinib（TAK-279）是一种高选择性、强效的TYK2抑制剂，用于中重度斑块状银屑病的治疗。一项Ⅱb期随机对照试验（NCT04999839）显示，患者服用15或30mg剂量后，第2周即出现临床改善。通过皮肤活检RNA测序和血清蛋白质组学分析发现： 1. **早期疗效相关机制**：第4周时，zasocitinib通过调节IL-23和I型干扰素通路信号，显著改善皮损（与PASI评分改善呈正相关，Spearman系数0.43/0.37，p<0.01）。 2. **生物标志物动态**：第4周观察到的关键组织标志物（如15个基因）变化，与第12周PASI改善显著相关（r=0.71，p<0.0001），且此关联在靶向IL-12/23、IL-17R或TNF的生物制剂中未出现。 3. **特异性优势**：zasocitinib对TYK2及疾病通路的调控早期（第4周）即与临床应答相关，提示其快速起效的独特潜力。 **结论**：Zasocitinib通过早期调控TYK2依赖性通路，可能成为银屑病的高效治疗选择。 2期临床研究 AAD 2026 2026-03-27 扎索替尼斑块状银屑病 Takeda Pharmaceutical Co., Ltd. P0164 Zasocitinib (TAK-279), an investigational oral, allosteric, highly selective and potent TYK2 inhibitor preserves anti-inflammatory IL-10 signalling in vitro - 药物发现/临床前 ECCO 2026 2026-02-18 扎索替尼炎症性肠病 Takeda Pharmaceuticals, Takeda Development Center Americas- Inc. | Institut d’Investigacions Biomèdiques August Pi I Sunyer IDIBAPS- Hospital Clínic, Inflammatory Bowel Disease Unit Leading artificial intelligence–driven drug discovery platforms: 2025 landscape and global outlook - 3期临床研究 Pharmacol Rev 2026-01-01 伦托司替 | 扎索替尼特发性肺纤维化 Centre for Cancer Cell Biology and Drug Discovery, Institute for Biomedicine and Glycomics, Griffith University, Southport, Queensland, Australia. Electronic address: m.dharmasivam@griffith.edu.au. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor 本研究评估了Zasocitinib（TAK-279）与已获许可的TYK2和JAK抑制剂相比的TYK2抑制效力和选择性。结果显示，Zasocitinib具有超过100万倍的选择性，对TYK2信号传导具有强效抑制作用，且不抑制JAK1/2/3。模拟临床浓度下，Zasocitinib每日30mg口服可在24小时内超过TYK2 IC50，保持>90%的每日抑制，且不抑制JAK1/2/3。Zasocitinib的独特强效和选择性抑制特性使其成为下一代TYK2抑制剂。药物发现/临床前 J Invest Dermatol 2026-01-01 扎索替尼 - Takeda Development Center Americas, Inc. Zasocitinib (TAK-279), an Investigational, Oral, Allosteric, Selective TYK2 Inhibitor, in Moderate-to-Severe Plaque Psoriasis: Efficacy Analysis by Baseline Characteristics from a Randomized Phase 2b Trial - 2期临床研究 ACR 2025 2025-10-24 扎索替尼斑块状银屑病 Takeda Development Center Americas, Inc. | Department of Dermatology, USC Keck School of Medicine, Los Angeles, CA Modulation of Tyrosine Kinase 2- and Disease-Related Biomarkers by Zasocitinib (TAK-279), an Oral, Allosteric, Highly Selective and Potent Tyrosine Kinase 2 Inhibitor, Is Associated With Clinical Response in Patients with Active Psoriatic Arthritis - 2期临床研究 ACR 2025 2025-10-24 扎索替尼银屑病关节炎 Takeda Development Center Americas, Inc. Modulation of Soluble Biomarkers of Cartilage and Bone Turnover and Inflammation by Zasocitinib (TAK-279), an Oral, Allosteric, Highly Selective and Potent TYK2 Inhibitor, is Associated with Clinical Response in Patients with Active Psoriatic Arthritis - 2期临床研究 ACR 2025 2025-10-24 扎索替尼银屑病关节炎 Takeda Development Center Americas, Inc. Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study - 2期临床研究 Ann Rheum Dis 2025-10-01 扎索替尼银屑病关节炎 Takeda Development Center Americas, Inc. | Altoona Center for Clinical Research | HW MedAdvice LLC | Takeda Development Center Americas, Inc, Cambridge, MA, USA. Electronic address: elena.muensterman@takeda.com. MODULATION OF SOLUBLE BIOMARKERS OF CARTILAGE AND BONE TURNOVER AND INFLAMMATION BY ZASOCITINIB (TAK-279), AN ORAL, ALLOSTERIC, HIGHLY SELECTIVE AND POTENT TYK2 INHIBITOR, IS ASSOCIATED WITH CLINICAL RESPONSE IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS - 2期临床研究 EULAR 2025 2025-06-11 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. ZASOCITINIB (TAK-279), AN ORAL, ALLOSTERIC, SELECTIVE TYK2 INHIBITOR, IN MODERATE-TO-SEVERE PLAQUE PSORIASIS: EFFICACY ANALYSIS BY BASELINE CHARACTERISTICS FROM A RANDOMISED PHASE 2B TRIAL - 2期临床研究 EULAR 2025 2025-06-11 扎索替尼斑块状银屑病 Takeda Development Center Americas, Inc. | Department of Dermatology, USC Keck School of Medicine, CA, United States of America Zasocitinib (TAK-279) exhibits high levels of TYK2 inhibition and no inhibition of JAK 1/3 when compared with licensed TYK2 and JAK inhibitors - 药物发现/临床前 EULAR 2025 2025-06-11 扎索替尼银屑病 | 炎症 Takeda Development Center Americas, Inc. ZASOCITINIB (TAK-279), A HIGHLY SELECTIVE ORAL TYROSINE KINASE 2 (TYK2) INHIBITOR, ELICITS MINIMAL DISEASE ACTIVITY AND EARLY SKIN RESPONSES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMISED PHASE 2B STUDY - 2期临床研究 EULAR 2025 2025-06-11 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. ASSESSMENT OF LABORATORY PARAMETER CHANGES IN A PHASE 2b TRIAL OF ZASOCITINIB (TAK-279), AN ORAL, HIGHLY SELECTIVE TYK2 INHIBITOR, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS - 2期临床研究 EULAR 2025 2025-06-11 扎索替尼银屑病关节炎 Takeda Development Center Americas, Inc. | University of California San Diego School of Medicine Zasocitinib (TAK-279) Displays High Levels of TYK2 Inhibition and No Inhibition of JAK 1/3 Compared with Licensed TYK2 and JAK Inhibitors - 药物发现/临床前 ACR 2024 2024-11-10 扎索替尼炎症 Takeda Development Center Americas, Inc. Assessment of Laboratory Parameter Changes in a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Highly Selective TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis - 2期临床研究 ACR 2024 2024-11-10 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study - 2期临床研究 ACR 2024 2024-11-10 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial - 2期临床研究 ACR 2024 2024-11-10 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. Influence of Patient Baseline Characteristics on Zasocitinib (TAK-279) Efficacy, a Selective Oral Tyrosine Kinase 2 Inhibitor: A Randomized Phase 2b Trial in Psoriatic Arthritis - 2期临床研究 ACR 2024 2024-11-10 扎索替尼银屑病关节炎 Takeda Pharmaceutical Co., Ltd. EVALUATING THE EFFICACY AND SAFETY OF ZASOCITINIB (TAK-279),A HIGHLY SELECTIVE ORAL TYROSINE KINASE 2 INHIBITOR, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: STUDY DESIGN FOR A PHASE 2B RANDOMIZED CLINICAL TRIAL 本研究旨在评估高度选择性口服酪氨酸激酶2（TYK2）抑制剂Zasocitinib（TAK-279）在中度至重度活动性克罗恩病（CD）患者中的疗效和安全性。研究设计为一项52周的随机、双盲诱导、安慰剂对照、剂量范围、持续治疗的临床试验。研究目标是评估Zasocitinib对CD患者的疗效和安全性，包括对生活质量的影响。主要疗效终点为在第12周达到内镜反应（SES-CD减少50%以上），次要疗效终点包括临床缓解、临床反应、内镜缓解、患者报告的症状和疾病特异性健康相关生活质量。安全性和耐受性将通过治疗相关的不良事件、严重不良事件和特别关注的不良事件进行评估。该研究已在进行中，首位患者于2024年3月随机入组。对于Zasocitinib反应者，计划进行开放式延长研究。 2期临床研究 UEGW 2024 2024-10-13 扎索替尼克罗恩病 Takeda Development Center Americas, Inc. | Western University Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial 本研究旨在评估高度选择性的变构酪氨酸激酶2（TYK2）抑制剂Zasocitinib在中度至重度斑块状银屑病患者中的疗效、安全性和耐受性。研究结果显示，口服每日5毫克或更高剂量的Zasocitinib对皮肤清除的效果优于安慰剂，且安全性良好。该研究为治疗银屑病提供了潜在的新口服治疗方案。 2期临床研究 JAMA Dermatol 2024-10-01 扎索替尼斑块状银屑病 Takeda Pharmaceutical Co., Ltd. EFFICACY AND SAFETY OUTCOMES OF TAK-279, A SELECTIVE ORAL TYROSINE KINASE 2 (TYK2) INHIBITOR, FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS 本研究旨在评估TAK-279在活动性牛皮癣性关节炎（PsA）患者中的疗效和安全性。研究结果显示，TAK-279在12周的治疗中，与安慰剂相比，15mg和30mg剂量组的患者达到ACR 20反应的比例显著更高，ACR 50反应率也更高。在PASI 75反应方面，30mg组最高。所有TAK-279组的TJC/SJC均值变化均有所减少，其中15mg和30mg剂量组的减少幅度更大。与安慰剂相比，所有TAK-279组的PhGA均有改善。总体而言，TAK-279在活动性PsA患者中表现出良好的耐受性，并且在12周的治疗中显示出优于安慰剂的剂量依赖性疗效。感谢牛津制药基因公司提供的医学写作支持，该支持由武田美洲发展中心资助。 2期临床研究 EULAR 2024 2024-06-05 扎索替尼银屑病关节炎 Takeda Development Center Americas, Inc. | Altoona Center for Clinical Research, Duncansville, United States of America | Leiden University Medical Center, Leiden, Netherlands Clinical efficacy of TAK-279, a highly selective oral tyrosine kinase 2 (TYK2) inhibitor, is associated with modulation of disease and TYK2 pathway biomarkers in patients with moderate-to-severe psoriasis **总结：TAK-279治疗中重度银屑病的临床疗效与生物标志物调控相关** TAK-279是一种高选择性口服TYK2抑制剂。一项2b期研究（NCT04999839）显示其在中重度银屑病患者中疗效显著且安全性良好，并探讨了TAK-279对银屑病/TYK2通路生物标志物的调控与临床/组织学应答的关联。研究对44例患者的皮肤活检和252例患者的血清样本进行分析。结果显示： 1. **临床应答**（≥PASI-75）：88%的应答者（21/24）在第12周时角质形成细胞标志物KRT16表达降低>87%。 2. **组织学应答**：72%的应答者（18/25）的IL-17A/F表达降低>80%。 3. **血清标志物**：所有TAK-279组均观察到剂量和时间依赖性的IL-17A/C/F水平下降。 4. **基因表达**：15mg和30mg组中，关键银屑病/TYK2标志物（如DEFB4A、IL-36G等）恢复至非皮损水平；PASI-90应答者（12例）的50个上调基因中48个表达正常化。 5. **组织学改善**：所有剂量组均见表皮厚度、CD3+ T细胞和CD11c+树突细胞减少。 **结论**：TAK-279通过调控银屑病/TYK2通路生物标志物，显著改善临床及组织学应答，支持其治疗潜力。 2期临床研究 AAD 2024 2024-03-08 扎索替尼银屑病 Takeda Pharmaceutical Co., Ltd. P143 Efficacy of the oral tyrosine kinase 2 (TYK2) inhibitor TAK-279 in two preclinical mouse models of colitis - 药物发现/临床前 ECCO 2024 2024-02-21 扎索替尼炎症性肠病 Hooke Laboratories, Inc. | Takeda Development Center Americas- Inc., Gastroenterology Drug Discovery Unit Exploratory exposure – response analyses for skin responses from the randomized, double-blind, placebo- controlled phase 2b trial of the oral TYK2 inhibitor TAK-279 in moderate-to-severe psoriasis 这项研究报告了口服TYK2抑制剂TAK-279在中度至重度银屑病患者中的皮肤反应探索性暴露反应分析结果。研究得出结论，TAK-279的最高剂量（30毫克）产生了与更多患者提前和最大皮肤反应相关的暴露水平，包括PASI 100和BSA <1%。该研究由Nimbus Discovery, Inc.和Takeda Development Center Americas, Inc.资助。研究使用双盲、安慰剂对照设计，将中度至重度斑块状银屑病患者随机分为四个TAK-279剂量组和安慰剂组。结果显示，TAK-279的不同剂量组与皮肤反应呈剂量和暴露相关关系，而不良事件发生率与剂量无关。这些发现有助于进一步了解TAK-279在治疗银屑病中的潜在作用和安全性。 2期临床研究 EADV 2023 2023-10-11 扎索替尼银屑病 Takeda Development Center Americas, Inc. Patient-reported outcomes in the randomized, double-blind, placebo-controlled phase 2b trial of the oral TYK2 inhibitor TAK-279 in moderate-to-severe psoriasis 该研究报告了口服TYK2抑制剂TAK-279在中度至重度银屑病患者中的随机、双盲、安慰剂对照2b期试验中患者报告的结果。研究发现，TAK-279治疗组在12周内DLQI和瘙痒NRS等患者报告的生活质量和银屑病症状方面均显著改善，尤其是在较高剂量组中观察到最显著的效果。这些积极的患者报告结果与TAK-279在皮肤反应方面的疗效相一致，表明TAK-279对减轻银屑病症状具有显著满意度。该研究由Nimbus Discovery, Inc./Takeda Development Center Americas, Inc.资助。研究介绍了TAK-279作为高选择性口服酪氨酸激酶2（TYK2）的变构抑制剂，对银屑病等自身免疫性疾病的治疗潜力。研究材料包括了一项随机、双盲、安慰剂对照的研究，共有259名患者参与。研究结果显示，TAK-279治疗组在DLQI和瘙痒NRS方面的改善均显著优于安慰剂组，且在15mg和30mg剂量组中观察到了剂量-反应关系。这些结果表明TAK-279对改善银屑病患者的生活质量和症状具有显著效果。 2期临床研究 EADV 2023 2023-10-11 扎索替尼银屑病 Takeda Pharmaceutical Co., Ltd. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. 本研究发现了一种强效且选择性的酪氨酸激酶2（TYK2）抑制剂：TAK-279。TYK2是IL12、IL23和类型I干扰素信号传导的关键介质，这些细胞因子已被证实与多种炎症性和自身免疫性疾病的发病机制相关，如银屑病、类风湿性关节炎、红斑狼疮和炎症性肠病。人类全基因组关联研究和临床结果支持通过小分子TYK2抑制剂治疗这些疾病的吸引力。本研究报告了一系列高选择性的假激酶（Janus亲缘蛋白2，JH2）结构域抑制剂，该研究运用了计算物理学预测的策略，包括使用FEP+，鉴定了一种吡唑啉-嘧啶核心结构。我们强调了计算物理学预测在优化这一系列分子中的实用性，以确定开发候选物30号，一种有效、高度选择性的细胞TYK2抑制剂，目前正处于治疗银屑病和银屑病性关节炎的2期临床试验中。药物发现/临床前 J Med Chem 2023-07-10 扎索替尼银屑病 | 银屑病关节炎 Nimbus Therapeutics LLC | Schrödinger, Inc.

2026-04-10

·赛柏蓝

为三终端市场注入新动力·神威药业肝胆、消化、儿科3大领域7大黄金单品重磅招商

神威药业重磅产品隆重招商 1.寻找全国/省/市/终端实力代理商。 2.寻找长线合作，稳健共赢的优质伙伴。 3.有成熟团队或能快速组建团队，或有成熟分销体系。 4.具有较强的市场营销、合规、分析、推广能力优先。神威药业为合作代理商提供全方位的支持市场推广支持：提供专业的市场推广方案和宣传物料。学术支持：线上线下学术活动，丰富的循证证据。市场渠道管理：严格管理市场，渠道有序，保护广大代理商利益。配送商网络支持：完善的产品配送商体系，确保货物及时配送，减缓代理商回款资金压力。售后服务支持：售后快速响应机制，解决代理商后顾之忧。龙胆泻肝软胶囊——千年传承清泻肝胆湿热良药产品资质：神威独家剂型 OTC甲类产品产品优势： 1.大品类、高潜力 –肝胆湿热涵盖范围广适合多种疾病，肝胆湿热证临床表现胁肋胀痛或灼热疼痛、剧痛，口苦口黏，胸闷纳呆，恶心呕吐，小便黄赤，大便不爽，或兼有身热恶寒，身目发黄；舌红苔黄腻，脉弦滑数。涵盖肝胆疾病、头面部炎症、皮肤病、泌尿系统、妇科、男科等多种疾病。 2.好品种、高价值 —— 成份稳定、好吸收、口感好 1)有效成份稳定：提取有效成份入药,完全避免氧化，提高了疗效（丸剂为原粉入药）； 2)生物利用度高：克服了固体剂型药物吸收差、起效慢的缺点（原粉入药受消化系统影响较大）； 3)口感好、不苦口：克服了颗粒剂和口服液具有的不良口味； 4)服用方便：方便使用、携带。 3.治疗明确，应用科室多 1)适应症：清肝胆，利湿热。用于肝胆湿热，头晕目赤，耳鸣耳聋，耳肿疼痛，胁痛口苦，尿赤涩痛，湿热带下； 2)适用渠道：三终端（诊所、卫生室、乡镇卫生院）、OTC 连锁药店、单体药店、民营医院、综合医院、社区卫生服务中心； 3)适用科室：肝病科、消化内科、肝胆外科、皮肤科、妇科、泌尿外科、男科等。 4. 权威指南推荐，临床证据充分利肝隆颗粒——保肝护肝肝炎首选产品资质：国家医保乙类产品优势： 1.市场广阔——《中国肝病流行病学和疾病负担》统计报告：中国肝病患病人数已经突破4亿，其中有约2亿人为非酒精脂肪肝，还有约6000万人为酒精肝。病毒性肝炎在我国患病率较高，约有 7000万例慢性乙型肝炎病毒（HBV）感染者和 1000 万例慢性丙型肝炎病毒（HCV）感染者。 2.治疗证型广泛，可用于治疗各种急、慢性肝炎 1)组方全面：利肝隆颗粒全面对抗“郁、虚、湿、毒、瘀”5大病机，适用各种证型肝病； 2)保肝护肝，肝炎首选，可以治疗各种急慢性肝炎。 3.治疗明确，应用科室多 1)适应症：疏肝解郁，清热解毒，益气养血。用于肝郁湿热、气血两虚所致的两胁胀痛或隐痛、乏力、尿黄；急、慢性肝炎见上述证候者； 2)适用渠道：三终端（诊所、卫生室、乡镇卫生院）OTC 连锁药店、单体药店、民营医院、综合医院、社区卫生服务中心； 3)适用科室：肝病科、感染科、消化内科、肝胆外科、核医学科等。胃肠宁颗粒产品资质：OTC 甲类中成药药理作用： 1.调节胃肠道功能：改善由脾胃虚弱引起的不适现象，如食欲不振、消化不良等；可用于治疗慢性结肠炎、溃疡性结肠炎等疾病引起的腹泻症状，通过收敛肠道、减少肠道蠕动来恢复胃肠正常功能； 2.抗炎镇痛：具有抗炎镇痛作用。当胃肠道存在炎症反应时，可能会出现腹部疼痛的情况，此时可以在医生的指导下使用该药物进行治疗； 3.清热祛湿：能够清除体内的湿热之邪，通过促进体内湿气的排出，调节津液代谢，从而改善因湿热阻滞引起的脘腹胀满、大便黏腻等症状； 4.温中止痛：可温暖中焦脾胃，驱散寒邪，能缓解脾胃虚寒导致的胃脘冷痛、喜温喜按等症状。同时，它还能调节胃肠道的气血运行，进一步减轻疼痛； 5.促进消化：有助于调节脾胃功能，提高食欲。该药物能增加胃液分泌，增强消化酶活性，从而加速食物在体内的消化吸收过程，缓解消化不良的症状； 6.调节胃肠道菌群：对胃肠道菌群的调节作用，有助于恢复肠道微生态平衡，减少有害细菌的生长，从而改善腹胀、腹泻等症状。止腹泻，调肠炎护肠道。产品优势： 1.适用于多种胃肠道疾病的治疗，不破坏肠胃正常菌落环境，具有调理肠胃、缓解不适、促进消化、保护胃黏膜以及改善胃肠功能； 2.服用方便：颗粒剂型，开水冲服即可，无需复杂的煎煮过程，服用方便快捷，口感适中，易于吸收； 3.安全性佳：纯中药制成，组方温和，符合传统用药特点，日常使用更放心。适用场景：消化科、儿科、中医科。参苓白术散产品资质：OTC 乙类医保甲类产品优势： 1.经典名方，千年健脾基础方：源自经典方剂，组方严谨，临床认可度高，脾胃调理刚需大。 2.神威大品牌，品质稳定可靠：大厂生产，质量可控，渠道信任度高，终端好推、易上量。 3.OTC 乙类 + 医保甲类，双渠道优势：药店动销快，基层医疗、诊所、社区可报销，复购稳定。 4.适用人群广，复购率高：脾胃虚弱、消化不良、便溏、体虚乏力等，家庭常备、长期调理需求强。 5.散剂剂型，吸收好、服用方便：6g 标准袋，冲服便捷，老人、儿童（遵医嘱）依从性好。适用场景：消化科、中医科、儿科、康复科、老年科涩肠止泻散产品资质：独家品种医保乙类 OTC甲类产品优势： 1.独家专利研发，专业儿药，止泻专用涩肠止泻散是神威药业独家专利研发的儿童止泻药。组方源自云南著名彝医祖传秘方，临床使用上百年，对腹泻、腹痛、食少、腹胀等治疗效果显著。通过神威专利技术保障，最大限度维系原方，使产品质量更稳定、携带更方便。 2.蒙脱石散升级制剂，单品潜力超10亿元涩肠止泻散由膨润土、岩陀两个药味组成。膨润土的主要成分为蒙脱石，其含量为40％～90％，是止泻的主要成分。涩肠止泻散在蒙脱石的基础上增加岩陀，增加了消炎止痛之功效。目前蒙脱石散市场规模近10亿元，涩肠止泻散是蒙脱石散的升级制剂，是儿童止泻首选用药。 3. 止泻、止痛、护肠、健脾，填补临床空白涩肠止泻散是具有肠粘膜保护和肠道菌群调节的止泻药。止泻更快速：膨润土、岩陀双重止泻，快速起效。止泻更止痛：膨润土护肠止泻，岩陀消炎止痛，对于腹泻伴腹痛患者效果更佳。服用更安全：膨润土不入血，6小时排除体外。临床应用百年，安全性高。 4.治疗疾病明确，应用科室广泛功能主治：彝医：嗨补习希，嗨补扎凯奴。中医：收敛止泻，健脾和胃。用于脾胃气虚所致泄泻，及消化不良见上述症状者。适用科室：综合医院：儿科、感染科、脾胃科、内科、肠道门诊；专科医院：儿科、感染科、内科、脾胃科；治疗疾病：儿童（或成人）急慢性腹泻、消化不良、急慢性肠炎。临床证据：涩肠止泻散完成了由国家中医儿科学学科带头人、中华中医药学会儿科分会主任委员马融教授牵头的，全国17家医院参加的“涩肠止泻散治疗儿童急性水样便腹泻随机、双盲、多中临床研究”结果表明：涩肠止泻散治疗儿童急性水样便腹泻3天有效率90.38%，蒙脱石散86.67%，显效率涩肠止泻散优于蒙脱石散；涩肠止泻散在治疗腹痛起效时间和腹痛持续时间效果优于蒙脱石散。复方锌布颗粒产品资质：甲类OTC 产品优势： 1、发病率高、市场容量大我国每年有75%的人至少患一次感冒，也就是说每年有近10亿人至少需用一次感冒药物，冬春季发病率提高50%，我国感冒药市场发展前景十分可观。随着新冠疫情的过去，但截止2024年零售市场中成药类感冒药和化药类感冒药仍500亿的市场容量，随着人们自我疗愈的意识的增强，感冒药市场仍是前景广阔的市场。 2、科学组方，快速起效葡萄糖酸锌：锌离子能参与多种酶的合成与激活，有增强吞噬细胞的吞噬能力的作用，缩短病程恢复感冒引起的食欲不佳；布洛芬：具有解热镇痛作用，防止感冒引起的肌肉酸痛；马来酸氯苯那敏：抗组胺药，能减轻流涕、鼻塞、打喷嚏等症状。 3、成人、儿童均可服用家长对儿童用药安全性要求提高，神威药业荣获科技进步二等奖企业生产，大品牌背书；桔子味，儿童服药依从性高；成人也可以服用。 4、治疗感冒，应用科室/场景聚焦功能主治：用于缓解普通感冒或流行性感冒引起的发热、头痛、四肢酸痛、鼻塞、流涕、打喷嚏等症状。适用科室：儿科、呼吸内科、耳鼻喉科。其他终端：电商平台、药店OTC、村镇卫生室。硬脂酸红霉素颗粒青霉素过敏患者首选替代抗菌药物，临床刚需产品资质：独家批文产品特性：儿童专用、处方药、50mg 儿童专属规格产品优势：我国儿童人口基数庞大，呼吸道感染、社区获得性肺炎为儿童常见病、高发病。肺炎支原体占学龄前儿童呼吸道感染病原体56.7%，大环内酯类为临床首选。儿童抗生素使用中，大环内酯类居首位，市场需求刚性、持续稳定。儿童专用精品药稀缺，长线操作空间大、复购稳定。 1)精准对症：小儿肺炎支原体肺炎、肺炎衣原体肺炎、百日咳首选药物； 2)安全耐酸：品控严格、杂质少，耐酸不易分解，吸收快、副作用小； 3)依从性高：水果口味颗粒剂，儿童接受度高，喂药方便； 4)耐药率低：耐药率5.34%，显著低于阿奇霉素，临床疗效稳定； 5)联合优选：可与β- 内酰胺类联用，扩大抗菌谱、减少耐药。应用场景：科室 / 渠道全覆盖 1、适应症：肺炎支原体肺炎、肺炎衣原体肺炎、百日咳、急性扁桃体炎、急性咽炎、鼻窦炎、中耳炎、猩红热、蜂窝织炎、口腔感染、青霉素过敏患者替代治疗用药； 2、适用渠道：三终端（诊所、卫生室、乡镇卫生院）OTC 连锁药店、单体药店、民营医院、综合医院儿科、社区卫生服务中心； 3、适用科室：儿科、呼吸科、耳鼻喉科、全科、社区门诊。临床文献：《大环内酯类抗菌药物儿科临床应用专家共识（2025 年版）》《儿童肺炎支原体肺炎中西医结合诊治专家共识》《儿童社区获得性肺炎诊疗规范（2019 年版）》《中国儿童百日咳诊断及治疗建议》多部指南明确推荐为儿童支原体 / 衣原体感染首选神威药业招商登记入口神威战略合作招商电话 0311-88030077 声明：此篇文章受众仅为医药、医疗等健康产业专业伙伴，仅供医学药学专业人士参考使用，不能替代医嘱，不针对普通消费大众。

2024-10-16

·GlobeNewswire-Health Care

Calliditas Therapeutics to Present Four Abstracts at American Society of Nephrology (ASN) Kidney Week 2024

STOCKHOLM, Sweden, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX) (“Calliditas”), today announced upcoming presence and data presentations at the American Society of Nephrology Kidney Week 2024 in San Diego, California on October 23 – 27, 2024. Presentations will highlight an open-label extension study of the efficacy and safety of Nefecon (TARPEYO® (budesonide) delayed release capsules)) in patients with primary immunoglobulin A nephropathy (IgAN), results from a real-world case series of IgAN patients, and additional insights from biomarker analysis. “We look forward to attending ASN Kidney Week and sharing additional data that reinforce Nefecon as a cornerstone treatment in IgAN,” said Richard Philipson, Chief Medical Officer at Calliditas. "This conference offers a great opportunity to exchange scientific knowledge with leading experts in nephrology and contribute to discussions around innovative treatments, including our potentially disease-modifying option." The oral presentation and poster presentation details are below. Following the meeting, they will be available on the Presentations and Publications page on Calliditas’ corporate website. Oral Presentation Details: Title: “NeflgArd Open-Label Extension: Efficacy and Safety of Nefecon in Patients with IgAN Who Completed the 2-Year Phase 3 Trial”Date and Time: October 25, 2024 from 4:40 PM to 4:50 PM PTLocation: Room 6D, Convention Center Poster Presentation Details: Title: “Results from a real-world case series of IgAN patients who received at least 9 months of Tarpeyo”Date and Time:Location: October 25, 2024 from 10:00 AM to 12:00 PM PT Title: Specificity of Nefecon in Targeting Pathogenic IgA in IgA Nephropathy While Preserving Systemic Humoral ImmunityDate and Time: October 25, 2024 from 10:00 AM to 12:00 PM PT Title: Impact of Nefecon on Complement Pathways in IgA Nephropathy: An Analysis of Lectin, Alternative, and Terminal PathwaysDate and Time: October 25, 2024 from 10:00 AM to 12:00 PM PT For more information, visit booth 1920 or visit the ASN Kidney Week 2024 website here. INDICATION TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations. WARNINGS AND PRECAUTIONSHypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Immunosuppression and Increased Risk of Infection: Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed. Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi’s sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, measles). Corticosteroid therapy may decrease the immune response to some vaccines. Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects. ADVERSE REACTIONS In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). DRUG INTERACTIONS Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide. USE IN SPECIFIC POPULATIONSPregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Please see Full Prescribing Information. About TARPEYOTARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. About Primary Immunoglobulin A NephropathyPrimary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. For further information, please contact:Emma Santosegsantos@lifescicomms.com The information was sent for publication, through the agency of the contact persons set out above, on October 16, 2024, at 14.00 p.m. CET.

临床3期

100 项与硬脂酸红霉素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02184	硬脂酸红霉素	J01FA01 D10AF02 S01AA17	-

研发状态

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适应症	国家/地区	公司	日期
软下疳	日本	Viatris Healthcare GK	2003-02-27
复杂皮肤和皮肤结构感染	日本	Viatris Healthcare GK	2003-02-27
白喉	日本	Viatris Healthcare GK	2003-02-27
脓胸	日本	Viatris Healthcare GK	2003-02-27
淋病	日本	Viatris Healthcare GK	2003-02-27
子宫内感染	日本	Viatris Healthcare GK	2003-02-27
肺脓肿	日本	Viatris Healthcare GK	2003-02-27
淋巴结炎	日本	Viatris Healthcare GK	2003-02-27
淋巴管炎	日本	Viatris Healthcare GK	2003-02-27
乳腺炎	日本	Viatris Healthcare GK	2003-02-27
骨髓炎	日本	Viatris Healthcare GK	2003-02-27
中耳炎	日本	Viatris Healthcare GK	2003-02-27
冠周炎	日本	Viatris Healthcare GK	2003-02-27
肺炎	日本	Viatris Healthcare GK	2003-02-27
肾盂肾炎	日本	Viatris Healthcare GK	2003-02-27
猩红热	日本	Viatris Healthcare GK	2003-02-27
皮肤和皮肤结构感染	日本	Viatris Healthcare GK	2003-02-27
梅毒	日本	Viatris Healthcare GK	2003-02-27
破伤风	日本	Viatris Healthcare GK	2003-02-27
扁桃体炎	日本	Viatris Healthcare GK	2003-02-27

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02005029 (CTgov)	N/A	帕金森病	18	Erythromycin (Erythromycin)	壓鏇繭醖壓簾獵衊顧淵(醖鹹鹽鑰襯網衊夢壓製) = 製蓋築壓衊蓋憲積鬱顧襯壓遞壓鏇鹽築製網積 (選鑰衊壓餘夢遞網壓構, 66.5) 更多	-	2017-02-03
				placebo (Placebo)	壓鏇繭醖壓簾獵衊顧淵(醖鹹鹽鑰襯網衊夢壓製) = 廠築鬱窪製鑰廠構鬱遞襯壓遞壓鏇鹽築製網積 (選鑰衊壓餘夢遞網壓構, 40.6) 更多
NCT02481219 (CTgov)	N/A	结直肠癌	122	SUPREP oral sulfate solution+Erythromycin+PEG+Metoclopramide+Bisacodyl+Senna tablets (Bowel Preparation Regimen -Control)	襯遞廠蓋積壓壓製鬱積 = 鹽鹹鏇築齋網鑰蓋繭積構簾繭衊製築醖鏇艱鹹 (繭築鑰憲範構顧鹽顧壓, 製襯選鹽蓋鏇壓蓋壓積 ~ 鬱齋醖選窪鬱簾衊鹽簾) 更多	-	2016-07-11
				SUPREP oral sulfate solution with Gastrografin+Erythromycin+PEG+Metoclopramide+Bisacodyl+Senna tablets (Bowel Preparation Regimen-Test)	襯遞廠蓋積壓壓製鬱積 = 憲夢壓獵觸製簾壓構醖構簾繭衊製築醖鏇艱鹹 (繭築鑰憲範構顧鹽顧壓, 襯糧繭蓋蓋鹽膚壓鬱廠 ~ 遞壓夢繭膚顧夢築醖顧) 更多
NCT01379183 (CTgov)	临床2/3期	-	40	Barium Sulfate Solution+Erythromycin (Erythromycin)	餘齋艱醖夢繭襯壓網餘(衊築鹽膚襯觸餘鑰繭憲) = 淵淵艱窪鹽繭糧範蓋餘鹹窪範襯壓簾網鬱願網 (顧膚夢獵願選衊積齋構, 52) 更多	-	2014-01-27
				Placebo (Placebo)	餘齋艱醖夢繭襯壓網餘(衊築鹽膚襯觸餘鑰繭憲) = 觸選廠鏇簾膚觸醖繭築鹹窪範襯壓簾網鬱願網 (顧膚夢獵願選衊積齋構, 59) 更多
NCT01478256 (CTgov)	临床4期	睑缘炎	30	Besifloxocin (Besifloxocin)	餘鏇築鏇觸築廠襯壓築 = 鏇夢壓襯遞憲網積構襯鹽積齋築廠襯糧襯築壓 (餘製膚蓋淵膚襯簾製網, 憲窪鏇齋鑰夢獵鏇淵艱 ~ 膚製糧積製築鹹積鏇襯) 更多	-	2013-11-20
				Erythromycin (Erythromycin)	餘鏇築鏇觸築廠襯壓築 = 鹽願獵鏇繭繭鏇選膚糧鹽積齋築廠襯糧襯築壓 (餘製膚蓋淵膚襯簾製網, 艱獵築鹽衊築選衊壓繭 ~ 簾築鏇鑰餘窪鬱構齋憲) 更多
NCT00467831 (CTgov)	临床1/2期	Hermanski-Pudlak综合征 \| 肺纤维化 \| 白化病伴有出血性素质和色素性网状内皮细胞	3	Pravastatin+Erythromycin+N-Acetyl Cysteine+Losartan+Zileuton	鏇襯膚繭遞獵鑰積積衊 = 網壓廠衊繭窪醖觸糧選糧糧衊繭夢鹹窪膚醖蓋 (鹽淵醖淵鬱構鏇膚鹹鏇, 築範網鬱顧鑰網網餘糧 ~ 顧憲衊積艱醖願夢願網) 更多	-	2013-08-02
NCT00304187 (CTgov)	临床2期	暴食症 \| 神经性贪食症	29	Erythromycin (Erythromycin)	鬱遞窪鏇憲壓鏇夢選廠(簾鹹網簾衊顧夢鑰鬱蓋) = 範積艱鏇觸願選築襯簾憲鑰膚壓窪遞獵膚衊繭 (構衊簾製積簾齋餘艱鏇, 8.7) 更多	-	2013-07-30
				Placebo (Placebo)	鬱遞窪鏇憲壓鏇夢選廠(簾鹹網簾衊顧夢鑰鬱蓋) = 顧襯壓醖觸壓夢餘鏇鹹憲鑰膚壓窪遞獵膚衊繭 (構衊簾製積簾齋餘艱鏇, 10.9) 更多