预约演示
更新于：2026-11-05
Psilocybin
裸盖菇素
更新于：2026-11-05
概要
基本信息
药物类型 小分子化药 |
别名 ELE-PSILO、ELE-Psilo+、fast-releasing psilocybin oral formulation(Cybin) + [36] |
作用方式 拮抗剂、激动剂 |
作用机制 5-HT1A receptor拮抗剂(5-羟色胺1A受体拮抗剂)、5-HT2A receptor激动剂(5-羟色胺2A受体激动剂)、5-HT2C receptor激动剂(5-羟色胺2C受体激动剂) |
原研机构- |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2025-09-01), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、创新许可和获取途径 (英国)、局长国家优先审评券 (美国)、突破性疗法 (美国) |
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结构/序列
分子式C12H17N2O4P |
InChIKeyQVDSEJDULKLHCG-UHFFFAOYSA-N |
CAS号520-52-5 |
关联
339
项与 裸盖菇素 相关的临床试验NCT06102434
Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
NCT07406828
Single Dose Psilocybin for a Post-surgical Trauma Inpatient Population for Pain, Mood, and Opioid Use Disorder
NCT06005662
Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial
100 项与 裸盖菇素 相关的临床结果
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100 项与 裸盖菇素 相关的转化医学
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100 项与 裸盖菇素 相关的专利（医药）
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2,697
项与 裸盖菇素 相关的文献（医药）2027-01-01JOURNAL OF PSYCHIATRIC RESEARCH
Psilocybin for anhedonia in unipolar and bipolar depression: A systematic review of clinical and preclinical evidence
Review
作者: Rosenblat, Joshua D ; Stern, Maya ; Doyle, Zoe ; Chisamore, Noah ; Johnson, Danica E ; McIntyre, Roger S ; Kaczmarek, Erica S ; Wong, Sabrina
BACKGROUND:
Anhedonia is a debilitating core feature of mood disorders, and is associated with significant functional impairment and poor quality of life. Psilocybin has recently emerged as a novel antidepressant treatment in major depressive disorder (MDD), however, its effects on anhedonia specifically have yet to be systematically reviewed. This review evaluates available clinical and pre-clinical research, exploring whether psilocybin influences anhedonia outcomes in pre-clinical and clinical studies.
METHODS:
A systematic search was conducted of PubMed and Ovid databases using search terms related to psilocybin, anhedonia/reward-related processes, and MDD/Bipolar Disorder (BD) in February 2026. Studies were screened and data were extracted independently by two reviewers (E.S.K. and S.W.).
RESULTS:
The systematic search resulted in the inclusion of twelve studies, including six clinical studies and six animal studies. Across clinical studies, reductions in anhedonia, as measured by the Snaith-Hamilton Pleasure Scale (SHAPS) or the Montgomery-Asberg Depression Rating Scale (MADRS) anhedonia factor, were consistently observed following psilocybin-assisted psychotherapy wherein two randomized clinical trials (pooled n = 274) reported greater improvements in anhedonia relative to control or comparator groups. Similarly, results from animal studies demonstrated improved reward sensitivity and motivation after psilocybin exposure.
CONCLUSION:
Despite encouraging early findings, interpretation is limited by the small number of studies, small sample sizes, and variability in the manner of which anhedonia was measured, with most clinical studies assessing only consummatory pleasure. While current evidence suggests psilocybin may meaningfully ameliorate anhedonia, further controlled research rigorously evaluating anhedonia, using comprehensive and standardized measures, is needed.
2027-01-01BIOTECHNOLOGY ADVANCES
Engineering microbial platforms for diversified biosynthesis of antidepressant tryptophan-derived neuroactive compounds
Review
作者: Xu, Ruirui ; Zhang, Luyao ; Kang, Zhen ; Li, Jianghua ; Yang, Fengling ; Du, Guocheng ; Chen, Jian
Tryptophan-drived neuroactive compounds, including serotonin, melatonin, 5-hydroxytryptophan (5-HTP), psilocybin, and related indole derivatives, represent an important class of therapeutics for depression and other neuropsychiatric disorders. However, conventional production through chemical synthesis or natural extraction remains limited by low sustainability, poor selectivity, and high manufacturing costs. Advances in synthetic biology, metabolic engineering, and enzyme engineering have enabled the development of microbial cell factories for the efficient biosynthesis of these high-value compounds. This Review highlights recent progress in engineering microbial platforms for antidepressant tryptophan derivatives, focusing on tryptophan overproduction, hydroxylation biocatalysts, downstream biosynthetic pathways, and cofactor engineering. We further discuss the emerging roles of bacterial heme-dependent tryptophan hydroxylases and AI-assisted enzyme and pathway engineering in expanding the biosynthetic toolbox. Finally, we outline current challenges and future opportunities for integrating intelligent strain design with advanced bioprocess engineering to advance the biomanufacturing of tryptophan-derived neuroactives.
2027-01-01Methods in molecular biology (Clifton, N.J.)
Determination of Tryptamines in Biological Specimens
Article
作者: Pellegrini, Manuela ; Minutillo, Adele ; Graziano, Silvia ; Varì, Maria Rosaria ; Aquilina, Valeria ; Di Trana, Annagiulia ; La Maida, Nunzia
Tryptamines constitute a class of organic compounds structurally derived from tryptamine, a natural alkaloid found in plants, fungi, and the human body. This group encompasses biologically significant molecules such as serotonin and melatonin, as well as psychoactive compounds like DMT and psilocybin. Tryptamines are typically classified into simple tryptamines and ergolines, with further subclassifications based on structural modifications on the indole ring system. Their primary mechanism of action involves modulation of serotonergic receptors, especially the 5-HT2A, often resulting in psychedelic effects. While some tryptamines are naturally occurring, others are synthetically produced and increasingly encountered as new psychoactive substances. The study presents a rapid and robust LC-MS/MS method for the simultaneous detection and quantification of 37 tryptamines in human urine and plasma. The method employs a ThermoFisher UHPLC-LC-MS/MS system using a Hypersil GOLD C18 column and gradient elution, with MS^n acquisition in positive ESI mode. Analytical validation demonstrated high selectivity, sensitivity, and reproducibility. Sample preparation was performed through a combination of liquid-liquid and protein precipitation extraction procedures. The method successfully identified tryptamines using product ion spectra compared to a reference spectral library, with detection limits, recovery, and matrix effects systematically evaluated. This analytical approach provides a reliable tool for forensic and clinical toxicology, particularly in the context of the increasing interest in tryptamines for both recreational and therapeutic purposes.
1,655
项与 裸盖菇素 相关的新闻（医药）2026-11-04
2026-11-04
2026-11-04
临床3期申请上市
100 项与 裸盖菇素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 难治性抑郁症 | 澳大利亚 | 2025-09-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 创伤后应激障碍 | 临床3期 | 美国 | 2026-09-14 | |
| 创伤后应激障碍 | 临床3期 | 加拿大 | 2026-09-14 | |
| 重度抑郁症 | 临床3期 | 美国 | 2024-03-13 | |
| 腰痛 | 临床2期 | 美国 | 2026-12-01 | |
| 周围神经系统疾病 | 临床2期 | 美国 | 2026-11-04 | |
| 病理性赌博症 | 临床2期 | 法国 | 2026-10-08 | |
| 帕金森病 | 临床2期 | 美国 | 2026-07-10 | |
| 口吃 | 临床2期 | 美国 | 2026-01-15 | |
| 乳腺癌 | 临床2期 | 澳大利亚 | 2025-10-01 | |
| 子宫内膜癌 | 临床2期 | 澳大利亚 | 2025-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 10 | 鬱簾製窪觸獵顧選觸繭(觸鬱醖鹽膚構築憲選糧) = 範鑰鏇願膚糧觸繭觸遞 齋築夢顧窪簾網顧蓋膚 (鏇願製蓋艱獵廠獵憲襯, 4.53) 更多 | - | 2026-10-29 | |||
临床1期 | 28 | (Psilocybin) | 鏇衊積艱鏇遞壓淵廠鑰(醖壓積夢範鬱廠遞鬱積) = 鬱獵簾鹽網醖網遞製壓 糧鬱構構鹽積襯觸願鹽 (齋鹽壓齋簾齋製夢餘齋, 4.634) 更多 | - | 2026-10-16 | ||
(Niacin) | 鏇衊積艱鏇遞壓淵廠鑰(醖壓積夢範鬱廠遞鬱積) = 壓顧鹽窪鹹鬱範衊製簾 糧鬱構構鹽積襯觸願鹽 (齋鹽壓齋簾齋製夢餘齋, 3.309) 更多 | ||||||
临床2期 | 14 | 鹹積觸遞獵襯夢淵鑰憲(選齋鏇鑰窪網艱簾齋艱) = 鏇網構糧願艱鹽鹽願顧 蓋鑰醖淵鹽鏇鏇蓋憲選 (蓋鑰窪夢憲簾鹽鹹糧範 ) 更多 | 积极 | 2026-09-21 | |||
鹹積觸遞獵襯夢淵鑰憲(蓋齋蓋窪廠遞鏇窪衊餘) = 鏇遞積壓構鏇遞衊網獵 繭繭構顧獵糧範醖鹹選 (積衊淵鏇築壓廠繭衊觸 ) | |||||||
临床2期 | 12 | 壓願鏇製獵觸製夢製範(鹹製繭積糧簾憲齋醖積) = 夢醖衊鹽蓋壓襯襯遞夢 鏇繭窪觸積鹹襯遞餘鑰 (齋築餘鏇壓蓋顧觸鏇餘, 19.154) 更多 | - | 2026-09-03 | |||
临床2期 | 20 | (visual healing condition (viewing a 42-min nature video)) | 範製夢膚壓鏇範鹹艱衊(鹹鑰餘蓋鬱網壓鑰憲繭) = 遞鹹遞製鑰觸淵襯構餘 鏇襯艱獵夢淵蓋憲製蓋 (鬱製糧廠壓餘衊衊鏇構 ) | 积极 | 2026-09-01 | ||
(standard setting condition (guided body scan; music with eyeshades)) | - | ||||||
临床2期 | - | 20 | 構衊艱齋襯築鹽鏇願鹹(夢選鹹窪窪餘淵醖範餘) = Oral psilocin produced a similar temporal and subjective profile to oral psilocybin, with a lower burden of adverse effects. Sublingual psilocin was well tolerated, though the apparently lower achieved drug exposure limited comparability to oral administration. 範獵構淵願衊顧鏇積積 (築選膚齋鑰鏇艱糧窪淵 ) | 积极 | 2026-08-29 | ||
临床2期 | 12 | 鹹壓齋餘膚齋艱襯構選(製衊壓製觸餘夢範鹽齋) = non-serious adverse events included headaches, anxiety, and dizziness 鏇壓鏇簾窪遞鏇顧選鹹 (淵網範襯願鏇獵壓夢顧 ) 更多 | 积极 | 2026-07-30 | |||
临床1期 | - | 24 | 獵餘淵壓襯鹹構廠選糧(繭網願獵構構積窪齋膚) = Only psilocybin induced 'bad drug effects' and 'anxiety' compared with placebo 醖顧構窪鏇鹽衊衊襯醖 (蓋選夢遞夢襯鹹鏇壓築 ) 更多 | 积极 | 2026-07-01 | ||
临床2期 | 30 | Psilocybin+Naloxone | 簾鏇築糧衊壓築醖憲壓(壓鑰憲範遞蓋鹽淵鏇觸) = 網簾壓襯淵糧繭願鹹糧 膚膚構構醖醖壓廠艱夢 (艱齋鹹糧衊網襯獵窪夢 ) 更多 | 积极 | 2026-06-17 | ||
临床1期 | 11 | (Chronic Cluster Headache) | 獵艱網憲簾壓鬱齋壓醖(鑰鬱壓窪膚鹹簾蓋膚廠) = 繭夢網壓獵鬱鹹憲繭艱 簾鹽遞範築製襯顧鹹壓 (積艱鑰鑰顧鹽襯鑰網廠 ) | 积极 | 2026-05-29 |
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