Drugs / Mesdopetam
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03531060 | Nov 2016 → Apr 2017 | Parkinson disease | Integrative Research Laboratories AB | Completed | No outcome recorded |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT04435431 | Oct 2020 → Dec 2022 | Parkinson disease | Integrative Research Laboratories AB | Completed | Missed primary |
| Phase 2 | NCT03368170 | Apr 2018 → Jun 2019 | Parkinson disease | Integrative Research Laboratories AB | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | Integrative Research Laboratories AB | Results IRLAB presents integrated analysis of mesdopetam data at international conference – confirms robust efficacy results in the Phase II studies irlab.se ↗
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. |
| 2025-12-11 | Integrative Research Laboratories AB | Regulatory The European Patent Office intends to grant a new patent for IRLAB’s mesdopetam. irlab.se ↗ |
| 2025-05-13 | Integrative Research Laboratories AB | Regulatory IRLAB is granted a patent expanding the patent protection for the drug candidate mesdopetam in the US irlab.se ↗ |
| 2025-03-12 | Integrative Research Laboratories AB | Results IRLAB publishes preclinical data on mesdopetam in the esteemed European Journal of Neuroscience irlab.se ↗ |
| 2025-02-27 | Integrative Research Laboratories AB | Results IRLAB publishes Phase IIb data on mesdopetam in Movement Disorders Clinical Practice irlab.se ↗
The data analyses showed clinically meaningful and dose-dependent anti-dyskinetic effects of mesdopetam, although the primary efficacy endpoint, good ON-time, was not met in this Phase IIb study. |
| 2025-02-20 | Integrative Research Laboratories AB | Regulatory IRLAB receives positive feedback from EMA confirming alignment with FDA on Phase III program for Mesdopetam irlab.se ↗
IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB a company discovering and developing novel treatments for Parkinson’s disease, today announces that the European Medicines Agency (EMA) has provided positive feedback on the company’s proposed design for the Phase III program of mesdopetam. |
| 2025-01-23 | Integrative Research Laboratories AB | Regulatory IRLAB has received a waiver from the EMA regarding pediatric studies with mesdopetam in Parkinson’s Disease irlab.se ↗
EMA’s Paediatric Committee (“PDCO”) recommended, and EMA has granted, a waiver for mesdopetam for all pediatric subsets of the pediatric population to treat Parkinson’s disease. |
| 2024-10-29 | Integrative Research Laboratories AB | Results IRLAB reports continued progress ahead of the mesdopetam Phase III program irlab.se ↗
a meta-analysis recently presented at the MDS scientific conference confirms the pronounced effect against levodopa-induced dyskinesias in people with Parkinson’s disease. |
| 2024-03-19 | Integrative Research Laboratories AB | Results IRLAB’s mesdopetam displays antipsychotic properties in an advanced model of Parkinson’s disease psychosis irlab.se ↗
The studies concluded that mesdopetam displays key features associated with antipsychotic efficacy in this PD-P model and should be further explored as a potential novel treatment option for psychosis in Parkinson’s disease. |
| 2024-02-22 | Integrative Research Laboratories AB | Regulatory IRLAB has completed a successful End-of-Phase 2 meeting with the FDA on the design of the Phase III program for mesdopetam irlab.se ↗
The discussions during the meeting indicate alignment between the FDA and IRLAB on the design of the Phase III program. |
| 2024-01-03 | Integrative Research Laboratories AB | Regulatory IRLAB is granted an end-of-Phase 2 meeting with the FDA for the Phase III-ready mesdopetam program irlab.se ↗
Gothenburg, Sweden, January 3, 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the US FDA has granted IRLAB an end-of-Phase 2 meeting for the mesdopetam program on February 20, 2024. |
| 2023-12-18 | Integrative Research Laboratories AB | Regulatory IRLAB submits request for an end-of-Phase 2 meeting with the FDA for the Phase III-ready mesdopetam program irlab.se ↗ |
| 2023-08-21 | Integrative Research Laboratories AB | Results IRLAB provides update on mesdopetam’s Phase IIb study data and the plans toward Phase III irlab.se ↗
The results indicate that mesdopetam has dose-dependent anti-dyskinetic and anti-parkinsonian effects combined with a tolerability and safety profile not different from placebo, giving mesdopetam a unique position in the competitive landscape. |
| 2023-01-17 | Integrative Research Laboratories AB | Results IRLAB announces top-line results from Phase IIb trial of mesdopetam (IRL790) in Parkinson’s disease irlab.se ↗
IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced the top-line results from the Phase IIb study of mesdopetam in people with Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). |
| 2022-11-15 | Integrative Research Laboratories AB | Results IRLAB highlights new preclinical data indicating Phase IIb drug candidate mesdopetam’s powerful efficacy in Parkinson’s psychosis and PD-LIDs irlab.se ↗
IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, today announced that new preclinical data has been published providing insight on the mechanisms underlying antipsychotic and antidyskinetic efficacy of drug candidate mesdopetam (IRL790) in PD-P and PD-LIDs. |
| 2021-05-25 | Integrative Research Laboratories AB | Results IRLAB’s drug candidate mesdopetam’s Phase I results published in scientific journal PR&P irlab.se ↗
The study evaluated the safety, tolerability, and pharmacokinetics of escalating single and multiple doses of mesdopetam. |
| 2021-01-11 | Integrative Research Laboratories AB | Results IRLAB presents new data indicating that mesdopetam could prevent dyskinesia in Parkinson’s Disease irlab.se ↗
IRLAB (Nasdaq Stockholm: IRLAB A) has obtained new results from preclinical studies which indicate that the drug candidate mesdopetam also has the potential to prevent the development of levodopa-induced dyskinesias, involuntary and troublesome movements, in Parkinson’s Disease. |
| 2020-12-08 | Integrative Research Laboratories AB | Regulatory IRLAB strengthens patent protection for Phase IIb/III drug candidate mesdopetam irlab.se ↗
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the World Intellectual Property Organization, WIPO, has published a new patent application concerning drug candidate mesdopetam (IRL790). |
| 2020-10-01 | Integrative Research Laboratories AB | Regulatory IRLAB’s mesdopetam IND accepted by the US FDA irlab.se ↗
IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB’s investigational new drug application (IND) for the drug candidate mesdopetam (IRL790). |
| 2020-06-04 | Integrative Research Laboratories AB | Results IRLAB’s Phase IIb/III study in Parkinson’s disease to target Good ON irlab.se ↗
In-depth explorative analysis of data from the Phase IIa study with mesdopetam in Parkinson’s patients with LIDs (Levodopa Induced Dyskinesia) indicates that the daily time without troublesome dyskinesias, called “Good ON”, increases dose dependently. |
| 2020-05-06 | Integrative Research Laboratories AB | Results IRLAB’s clinical drug candidate mesdopetam published in JPET irlab.se ↗
An additional paper is also published in JPET, indicating that mesdopetam could have beneficial effects on neurotrophic factors important for preserved synaptic function and nerve cell signaling. |
| 2019-09-26 | Integrative Research Laboratories AB | Regulatory IRLAB’s IRL790 is proposed a unique INN by WHO irlab.se ↗
IRLAB announced today that the World Health Organization (WHO) has proposed the name mesdopetam as the International Nonproprietary Name (INN) for the company’s drug candidate IRL790. |
| 2019-08-28 | Integrative Research Laboratories AB | Results IRLAB to advance clinical development of IRL790 in LIDs based on in-depth analysis of positive Phase IIa results irlab.se ↗
IRLAB (Nasdaq First North Premier: IRLAB A) today announced that the in-depth analysis of the data from the recently concluded Phase IIa study of IRL790 in Parkinson’s patients with L-dopa induced dyskinesia (LIDs) brings further evidence of the drug candidate’s ability to significantly and meaningfully improve daytime movement quality. |
| 2019-07-16 | Integrative Research Laboratories AB | Results IRLAB reports top line results from Phase IIa study with IRL790 irlab.se ↗
IRLAB today announced initial results from a first 28-Day Phase IIa trial with IRL790 in patients with advanced Parkinson’s disease. |
| 2019-03-14 | Integrative Research Laboratories AB | Results IRLAB adds sites to Phase II study with IRL790 and passes DSMB’s second safety review irlab.se ↗
IRLAB announced today that the independent Data Safety Monitoring Board, DSMB, reported no safety concerns in their second review of the ongoing Phase IIa study with the drug candidate IRL790. |
| 2018-12-18 | Integrative Research Laboratories AB | Results IRLAB provides update on drug candidate IRL790’s clinical program irlab.se ↗
The study’s independent Data Safety Monitoring Board (DSMB) has reported that there were no safety concerns in the study. |
| 2018-12-06 | Integrative Research Laboratories AB | Results Nature’s npj Parkinson’s Disease publishes clinical study with IRLAB’s drug candidate IRL790 irlab.se ↗
The clinical Phase Ib study shows that IRL790 is well tolerated and has a very good safety profile. |
| 2017-11-15 | Integrative Research Laboratories AB | Regulatory IRLAB receives MHRA approval to conduct Phase II trials with IRL790 in Britain irlab.se ↗
IRLAB has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) to conduct a Phase II study with the drug candidate IRL790 for treatment of L-dopa induced dyskinesias (LIDs). |
All press releases naming this drug 49 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mesdopetam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03368170 ↗ |
| Known as | IRL790 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03531060 ↗ |
| Action | Inhibit | “Dopamine D3 receptor antagonist” CHEMBL4594447 ↗ |
| Modality | Small molecule | “Mesdopetam (IRL790) is an experimental small molecule compound” NCT03368170 ↗ |
| Route | Oral | “Capsule 2.5 mg, oral administration” NCT03368170 ↗ |
| Target | DRD3 | “Dopamine D3 receptor antagonist” CHEMBL4594447 ↗ |