A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease

This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.

开始日期2020-10-29

申办/合作机构

IRLAB Therapeutics AB

NCT03368170

/ Completed临床2期

A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia

Mesdopetam (IRL790) is an experimental small molecule compound with psychomotor stabilizing properties. The primary target is the dopamine D3 receptor, a target implicated in the generation of levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa treatment in patients with Parkinson's disease. In experimental animals mesdopetam potently reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect of levodopa.
The primary purpose of the trial is to investigate whether mesdopetam given as adjunctive treatment can reduce levodopa induced dyskinesia in patients with Parkinson's disease. The trial will also help to establish the most optimal dosing of the compound.

开始日期2018-04-12

申办/合作机构

IRLAB Therapeutics AB

[+1]

NCT03531060

/ Completed临床1/2期

A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).

This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.

开始日期2016-11-08

申办/合作机构

IRLAB Therapeutics AB

100 项与 Mesdopetam 相关的临床结果

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100 项与 Mesdopetam 相关的转化医学

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100 项与 Mesdopetam 相关的专利（医药）

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项与 Mesdopetam 相关的文献（医药）

2026-04-01·CURRENT OPINION IN NEUROBIOLOGY

The challenges of experimental pharmacology in identifying novel treatments for Parkinson's disease

Review

作者: Huot, Philippe ; Teil, Margaux

An important part of the field of experimental pharmacology encompasses the study of the effects of molecules in animals. In the case of Parkinson's disease (PD), animal models have played an invaluable role in refining our understanding of the disease, in characterizing the effect of new compounds on the illness, and in bringing new treatments to the clinic. Indeed, it is now hardly conceivable that a drug would be tested in humans if several parameters pertaining to safety, toxicology, efficacy, etc. had not previously been evaluated in animal models. Quite unfortunately, efficacy in experimental models of PD does not necessarily guarantee positive clinical outcomes. In this article, which primarily focusses on the past five years, we review drugs that entered clinical trials for the treatment of levodopa-induced dyskinesia, parkinsonism, disease modification, and had previously been assessed in animal models of PD. The drugs discussed are buspirone, JM-010, befiradol, mesdopetam, foliglurax, dipraglurant, tavapadon, prasinezumab, cinpanemab, nilotinib, minzasolmin, exenatide, NLY01, liraglutide, lixisenatide, and semaglutide. For each molecule, we examine how previous preclinical studies succeeded or failed in predicting efficacy in clinical trials and discuss possible ways to optimize animal-model design and selection to maximize the probability of translational success.

2025-06-01·Movement Disorders Clinical Practice

Mesdopetam for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease: A Randomized Phase 2b Trial

Article

作者: Angelo Antonini MD, PhD ; Joakim Tedroff MD, PhD ; Padraig O'Suilleabhain MD ; Susanna Waters MD, PhD ; Fabricio Stocchi MD, PhD ; Johanna Landström MSc ; Clas Sonesson PhD

Abstract:

Background:

The treatment of levodopa‐induced dyskinesia in Parkinson's disease (PD) is a largely unmet need.

Objectives:

Mesdopetam is a novel small molecule dopamine D3 receptor antagonist aimed for the treatment of levodopa‐induced dyskinesia. This was a phase 2b study dose finding study to investigate efficacy and safety of 2.5 mg, 5 mg and 7,5 mg b.i.d. in a randomized controlled trial.

Methods:

PD patients with ≥2 hours of troublesome dyskinesia were randomized to placebo or mesdopetam twice daily for 12 weeks. The primary efficacy endpoint was change from baseline to week 12 in ON time without troublesome dyskinesia (Good ON‐time) as recorded with home diaries. Secondary efficacy endpoints assessing ON phase dyskinesia were the modified UDysRS (sum of parts 1, 3 and 4) and MDS‐UPDRS part 4.2.

Results:

Groups did not differ in change from baseline to end of study in Good ON‐time. Several secondary assessments for ON phase dyskinesia such as the modified UDysRS showed clinically relevant and statistically significant improvements for the 2.5 and 7.5 mg doses. OFF time showed dose dependent decrease with highest efficacy for the 7.5 mg dose. The adverse event profile was similar to placebo.

Conclusions:

In this study mesdopetam failed to increase Good ON‐time as compared to placebo. However, a statistically significant and clinically meaningful improvement in the prespecified secondary efficacy endpoint UDysRS warrants further investigation. Results from this dose finding study suggest 7.5 mg b.i.d. to be the preferred dose for further study.

2025-03-01·EUROPEAN JOURNAL OF NEUROSCIENCE

Neurophysiological Treatment Effects of Mesdopetam, Pimavanserin and Amantadine in a Rodent Model of Levodopa‐Induced Dyskinesia

Article

作者: Petersson, Per ; Ronaghi, Abdolaziz ; Malinina, Evgenya ; Barrientos, Sebastian A. ; Sato, Sebastian Sulis ; Tedroff, Joakim ; Nasretdinov, Azat ; Censoni, Luciano ; Stan, Tiberiu Loredan ; Halje, Pär ; Waters, Nicholas

ABSTRACT:

Levodopa provides effective symptomatic treatment for Parkinson's disease. However, nonmotor symptoms are often insufficiently relieved, and its long‐term use is complicated by motor fluctuations and dyskinesia. To clarify mechanisms of levodopa‐induced dyskinesia and pharmacological interventions aimed at reducing dyskinetic symptoms, we have here characterized the neurophysiological activity patterns in sensorimotor and cognitive‐limbic circuits in dyskinetic rats, comparing the effects of amantadine, pimavanserin, and the novel prospective antidyskinetic and antipsychotic treatment mesdopetam. Parallel recordings of local field potentials from 11 cortical and subcortical regions revealed suppression of narrowband gamma oscillations (NBGs) in sensorimotor structures by amantadine and mesdopetam in conjunction with alleviation of dyskinetic signs. Concomitant gamma oscillations in cognitive‐limbic circuits were not directly linked to dyskinesia and were not affected by antidyskinetic treatments to the same extent, although treatment‐induced reductions in functional coupling were observed in both sensorimotor and cognitive‐limbic circuits, in parallel. In a broad frequency spectrum (1–200 Hz), mesdopetam treatment displayed greater similarities to pimavanserin than to amantadine. These findings point to the reduction of NBGs as a valuable biomarker for the characterization of antidyskinetic treatment effects and provide systems‐level mechanistic insights into the antidyskinetic efficacy of mesdopetam, with potential additional benefits for the treatment of Parkinson's‐related psychosis.

120

项与 Mesdopetam 相关的新闻（医药）

2026-06-16

·BioSpace

IRLAB Presents Integrated Analysis of Mesdopetam Data at International Conference - Confirms Robust Efficacy Results in the Phase II Studies

GOTHENBURG, SE / ACCESS Newswire / June 16, 2026 / IRLAB Therapeutics AB ((STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, today announces that an integrated analysis of clinical data for mesdopetam, IRLAB's most advanced drug candidate in development to treat levodopa-induced dyskinesia, will be presented at StanCon 2026 in Uppsala in August. The analysis confirms mesdopetam's anti-dyskinetic effect across a broad range of statistical models - a conclusion that strengthens the project's attractiveness in ongoing partnering discussions. The research will be presented by IRLABs, Erik Werner, PhD, Senior Data Scientist at IRLAB, at StanCon 2026 - the International Conference on Bayesian Inference and Probabilistic Programming - on August 17-21, 2026, in Uppsala. The conference brings together world-leading statisticians and is a recognized forum for advanced statistical analysis. The analysis is based on pooled data from IRLAB's randomized, placebo-controlled phase IIa and phase IIb studies of mesdopetam. The research team, led by Dr. Werner, has constructed and analyzed a large number of Bayesian statistical models. Although the numerical estimates may vary, the conclusion is unequivocal: The analysis confirms mesdopetam's favorable effect pro its anti-dyskinetic efficacyacross a broad range of statistical models. "It is encouraging that mesdopetam's effect on levodopa-induced dyskinesia can be confirmed in this extensive analysis based on two phase II studies and a large number of statistical models. The result is valuable for the project in the preparations for the next step in the clinical development program and strengthens our position in the ongoing discussions with potential partners," says Nicholas Waters, Executive Vice President & Head of R&D, IRLAB Therapeutics. Mesdopetam is a dopamine D3 receptor antagonist in clinical development for the treatment of levodopa-induced dyskinesia (LID) - a common and difficult-to-treat condition in Parkinson's disease. The analysis to be presented at StanCon 2026 builds on a Bayesian meta-analysis that was presented at the International Congress of the International Parkinson and Movement Disorder Society in 2024. For more information Kristina Torfgård, CEO Phone: +46 730 60 70 99 E-mail: kristina.torfgard@irlab.se Nicholas Waters, EVP and Head of R&D Phone: +46 730 75 77 01 E-mail: nicholas.waters@irlab.se About IRLAB IRLAB discovers and develops a portfolio of transformative treatments for all stages of Parkinson's disease. The company originates from Nobel Laureate Prof Arvid Carlsson's research group and the discovery of a link between brain neurotransmitter disorders and brain diseases. Mesdopetam (IRL790), under development for treating levodopa-induced dyskinesias, has completed Phase IIb and is in preparation for Phase III. Pirepemat (IRL752), currently in Phase IIb, is being evaluated for its effect on fall frequency in Parkinson's disease. IRL757, a compound being developed for the treatment of apathy in neurodegenerative disorders, is in Phase Ib. In addition, the company is developing two preclinical programs, IRL942 and IRL1117, towards Phase I studies. IRLAB's pipeline has been generated by the company's proprietary systems biology-based research platform Integrative Screening Process (ISP). Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . Attachments IRLAB presents integrated analysis of mesdopetam data at international conference - confirms robust efficacy results in the Phase II studies SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire

2026-06-05

·BioSpace

Report from the Extraordinary General Meeting of IRLAB Therapeutics AB

GOTHENBURG, SE / ACCESS Newswire / June 5, 2026 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) - IRLAB Therapeutics AB held its Extraordinary General Meeting today, Friday, 5 June 2026. The following main resolutions were made at the general meeting. Approval of the Board of Directors' resolutions on issues of new shares of series A, with preferential rights for existing shareholders and with deviation from the shareholders' preferential rights, respectively, as well as amendment of the articles of association The general meeting resolved to approve the Board of Directors' resolution from 5 May 2026 on an issue of new shares of series A with preferential rights for existing shareholders, and an issue of new shares of series A with deviation from the shareholders' preferential rights. The general meeting further resolved to adopt new articles of association, whereby the intervals for the share capital and the number of shares are amended to enable the issues of new shares. Election of new Board members and board remuneration The general meeting resolved, in accordance with the Nomination Committee's proposal, to elect Jan-Fredrik Backman and James Gamgort as new Board members. Following the general meeting, the Board of Directors consists of Carola Lemne, Christer Nordstedt, Gunnar Olsson, Rein Piir, Veronica Wallin, Jan-Fredrik Backman and James Gamgort. The Board of Directors thus consists of seven Board members for the period until the end of the next Annual General Meeting. The general meeting further resolved, in accordance with the Nomination Committee's proposal, that Jan-Fredrik Backman and James Gamgort shall be remunerated at the same level as the current ordinary Board members in accordance with the resolution from the Annual General Meeting 2025, however, that the remuneration shall be reduced proportionally to only cover the remaining days from the election at the Extraordinary General Meeting until the next Annual General Meeting. Minutes and complete resolutions The minutes from the general meeting, including the complete resolutions, will be available on the company's website ( ). For more information Kristina Torfgård, CEO Phone: +46 730 60 70 99 E-mail: kristina.torfgard@irlab.se Gustaf Albèrt, CFO Phone: +46 709 168 302 E-mail: gustaf.albert@irlab.se About IRLAB IRLAB discovers and develops a portfolio of transformative treatments for all stages of Parkinson's disease. The company originates from Nobel Laureate Prof Arvid Carlsson's research group and the discovery of a link between brain neurotransmitter disorders and brain diseases. Mesdopetam (IRL790), under development for treating levodopa-induced dyskinesias, has completed Phase IIb and is in preparation for Phase III. Pirepemat (IRL752), currently in Phase IIb, is being evaluated for its effect on fall frequency in Parkinson's disease. IRL757, a compound being developed for the treatment of apathy in neurodegenerative disorders, is in Phase Ib. In addition, the company is developing two preclinical programs, IRL942 and IRL1117, towards Phase I studies. IRLAB's pipeline has been generated by the company's proprietary systems biology-based research platform Integrative Screening Process (ISP). Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . Attachments Report from the Extraordinary General Meeting of IRLAB Therapeutics AB SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire

临床2期临床1期

2026-06-03

·BioSpace

IRLAB Participates at Aktiedagarna in Stockholm on June 9

GOTHENBURG, SE / ACCESS Newswire / June 3, 2026 / IRLAB Therapeutics AB (STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, announces that CEO Kristina Torfgård and CFO Gustaf Albèrt will participate in Aktiespararna's event Aktiedagarna in Stockholm. IRLAB's presentation will take place on Tuesday, June 9, 2026, at 16:25 and will be broadcast live via the following link: . It will also be available afterwards on the company's website, . Aktiedagarna is an investor event organized by Aktiespararna and will be held at Birger Jarl Conference in Stockholm on June 9-10. The event is a hybrid meeting that brings together investors, companies, and industry experts, and can be attended both in person and digitally. For more information Kristina Torfgård, CEO Phone: +46 730 60 70 99 E-mail: kristina.torfgard@irlab.se About IRLAB IRLAB discovers and develops a portfolio of transformative treatments for all stages of Parkinson's disease. The company originates from Nobel Laureate Prof Arvid Carlsson's research group and the discovery of a link between brain neurotransmitter disorders and brain diseases. Mesdopetam (IRL790), under development for treating levodopa-induced dyskinesias, has completed Phase IIb and is in preparation for Phase III. Pirepemat (IRL752), currently in Phase IIb, is being evaluated for its effect on fall frequency in Parkinson's disease. IRL757, a compound being developed for the treatment of apathy in neurodegenerative disorders, is in Phase Ib. In addition, the company is developing two preclinical programs, IRL942 and IRL1117, towards Phase I studies. IRLAB's pipeline has been generated by the company's proprietary systems biology-based research platform Integrative Screening Process (ISP). Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit . Attachments IRLAB participates at Aktiedagarna in Stockholm on June 9. SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire

临床2期临床1期

100 项与 Mesdopetam 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
药物性运动障碍	临床2期	美国	IRLAB Therapeutics AB	2020-10-29
药物性运动障碍	临床2期	法国	IRLAB Therapeutics AB	2020-10-29
药物性运动障碍	临床2期	以色列	IRLAB Therapeutics AB	2020-10-29
药物性运动障碍	临床2期	意大利	IRLAB Therapeutics AB	2020-10-29
药物性运动障碍	临床2期	波兰	IRLAB Therapeutics AB	2020-10-29
药物性运动障碍	临床2期	塞尔维亚	IRLAB Therapeutics AB	2020-10-29
帕金森病	临床2期	瑞典	IRLAB Therapeutics AB	2018-04-12
帕金森病	临床2期	英国	IRLAB Therapeutics AB	2018-04-12
运动失调	临床2期	-	IRLAB Therapeutics AB	2016-11-08

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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


NCT04435431 (CTgov)	临床2期	药物性运动障碍 \| 帕金森病	155	Placebo	憲艱範鹹齋蓋艱網鹽膚(鏇餘膚鬱願蓋糧願顧網) = 夢壓鏇構鑰鬱膚鹽廠願憲鑰選觸艱鹹顧製蓋積 (遞積網蓋淵鹹蓋夢襯醖, 0.4776) 更多	-	2024-03-06
NCT04435431 \| EUCTR2020-002010-41-FR (Biospace) 人工标引	临床2期	帕金森病	156	mesdopetam	顧願構醖觸構餘遞衊遞(製憲獵鹽積鏇鏇繭齋選) = 觸築淵鏇鏇鹹艱淵鑰範廠膚膚窪積襯鑰鹹襯壓 (糧觸製願築膚選齋糧鏇 ) 更多	积极	2023-08-21
NCT04435431 \| EUCTR2020-002010-41-FR (Biospace) 人工标引	临床2期	帕金森病	156	placebo	築衊觸鹽憲蓋蓋衊淵鏇(遞獵範網鹹遞願遞選膚) = 築繭艱積願膚襯鹽淵窪製蓋餘憲鹽醖窪願築憲 (艱糧醖襯範衊艱廠鬱網 ) 更多	积极	2023-08-21
NCT03368170 (CTgov)	临床2期	帕金森病	75	Mesdopetam	選膚築廠願淵簾廠襯遞(膚願範鬱顧醖鑰餘鏇衊) = 壓壓獵選積鹹齋顧積觸蓋構蓋願淵壓鏇齋艱願 (憲製築鹽構構築夢醖糧, 夢觸壓鏇壓糧蓋願顧憲 ~ 膚艱積鹹選製獵鏇餘鹹) 更多	-	2020-03-24
NCT03531060 (Pubmed \| NPJ Parkinsons Dis) 人工标引	临床1期	运动失调 \| 帕金森病	15	IRL790	蓋餘選獵糧糧鏇廠夢遞(窪鏇遞艱蓋簾觸鹽繭鹽) = 選蓋築憲網餘觸餘遞構觸鬱餘範夢築鏇壓製範 (廠構觸積鏇鹹壓壓觸獵 ) 更多	积极	2018-12-06
NCT03531060 (Pubmed \| NPJ Parkinsons Dis) 人工标引	临床1期	运动失调 \| 帕金森病	15	Placebo	蓋餘選獵糧糧鏇廠夢遞(窪鏇遞艱蓋簾觸鹽繭鹽) = 壓餘製夢壓獵膚鏇繭醖觸鬱餘範夢築鏇壓製範 (廠構觸積鏇鹹壓壓觸獵 ) 更多	积极	2018-12-06
MDS2018	临床1期	药物性运动障碍 \| 帕金森病 dopamine D3 receptor	-	IRL790	憲願夢構範顧蓋衊夢艱(蓋顧夢夢製願鏇積齋壓) = Adverse events were mostly reported during the titration phase of the trial. They were mainly central nervous system related and could be mitigated by dose adjustments. There were no serious adverse events. 網淵構獵膚製衊鑰鏇憲 (鹹醖鹹製構糧壓蓋蓋窪 ) 更多	积极	2018-10-05