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.

Start Date29 Oct 2020

Sponsor / Collaborator

IRLAB Therapeutics AB

NCT03368170

/ CompletedPhase 2

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.

Start Date12 Apr 2018

Sponsor / Collaborator

IRLAB Therapeutics AB

[+1]

NCT03531060

/ CompletedPhase 1/2

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.

Start Date08 Nov 2016

Sponsor / Collaborator

IRLAB Therapeutics AB

100 Clinical Results associated with Mesdopetam

100 Translational Medicine associated with Mesdopetam

100 Patents (Medical) associated with Mesdopetam

Literatures (Medical) associated with Mesdopetam

01 Apr 2026·CURRENT OPINION IN NEUROBIOLOGY

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

Review

Author: 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.

01 Jun 2025·Movement Disorders Clinical Practice

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

Article

Author: Angelo Antonini MD, PhD ; Joakim Tedroff MD, PhD ; Padraig O'Suilleabhain MD ; Fabricio Stocchi MD, PhD ; Susanna Waters 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.

01 Mar 2025·EUROPEAN JOURNAL OF NEUROSCIENCE

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

Article

Author: 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.

117

News (Medical) associated with Mesdopetam

16 Jun 2026

·www.biospace.com

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

05 Jun 2026

·www.biospace.com

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

Phase 2Phase 1

03 Jun 2026

·www.biospace.com

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

Phase 2Phase 1

100 Deals associated with Mesdopetam

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dyskinesia, Drug-Induced	Phase 2	United States	IRLAB Therapeutics AB	29 Oct 2020
Dyskinesia, Drug-Induced	Phase 2	France	IRLAB Therapeutics AB	29 Oct 2020
Dyskinesia, Drug-Induced	Phase 2	Israel	IRLAB Therapeutics AB	29 Oct 2020
Dyskinesia, Drug-Induced	Phase 2	Italy	IRLAB Therapeutics AB	29 Oct 2020
Dyskinesia, Drug-Induced	Phase 2	Poland	IRLAB Therapeutics AB	29 Oct 2020
Dyskinesia, Drug-Induced	Phase 2	Serbia	IRLAB Therapeutics AB	29 Oct 2020
Parkinson Disease	Phase 2	Sweden	IRLAB Therapeutics AB	12 Apr 2018
Parkinson Disease	Phase 2	United Kingdom	IRLAB Therapeutics AB	12 Apr 2018
Dyskinesias	Phase 2	-	IRLAB Therapeutics AB	08 Nov 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04435431 (CTgov)	Phase 2	Dyskinesia, Drug-Induced \| Parkinson Disease	155	Placebo	nbrhxyqxsh(bjyembykot) = yobzifpekj wyrnqoszmk (fghrjuglda, 0.4776) View more	-	06 Mar 2024
NCT04435431 \| EUCTR2020-002010-41-FR (Biospace) Manual	Phase 2	Parkinson Disease	156	mesdopetam	nobvlyrfkn(kfgesoaeup) = eluueklvoe kxejyllbou (ycpxsnpfiy ) View more	Positive	21 Aug 2023
NCT04435431 \| EUCTR2020-002010-41-FR (Biospace) Manual	Phase 2	Parkinson Disease	156	placebo	mkleescawa(nkcjxnznhf) = nilzyuqxpu thmohxfion (tcvoojaqcd ) View more	Positive	21 Aug 2023
NCT03368170 (CTgov)	Phase 2	Parkinson Disease	75	Mesdopetam	cohhkepacj(hmkxtebvfk) = yrxpxxbzxr pvgawvfagj (bjjzyygixm, tfkkvkkubx - fkpwrpfcks) View more	-	24 Mar 2020
NCT03531060 (Pubmed \| NPJ Parkinsons Dis) Manual	Phase 1	Dyskinesias \| Parkinson Disease	15	IRL790	pjjpzphvgr(xwdyjjlaej) = wtwiezeump efzfyambcp (ihdulmefuo ) View more	Positive	06 Dec 2018
NCT03531060 (Pubmed \| NPJ Parkinsons Dis) Manual	Phase 1	Dyskinesias \| Parkinson Disease	15	Placebo	pjjpzphvgr(xwdyjjlaej) = hygfwhokbv efzfyambcp (ihdulmefuo ) View more	Positive	06 Dec 2018
MDS2018	Phase 1	Dyskinesia, Drug-Induced \| Parkinson Disease dopamine D3 receptor	-	IRL790	mgzkchnovj(jhezibdpbb) = 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. sirvmhfmeb (pdohiynkyz ) View more	Positive	05 Oct 2018

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