Drugs / Pridopidine
Pridopidine
also known as
ACR16 · ACR-16 HYDROCHLORIDE · ACR16 HCL · ASP-2314 HCL · ASP-2314 HYDROCHLORIDE · FR-310826 · Huntexil · Pridopidina · +2 more
Small molecule targets DRD2
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | — | Huntington disease | 2025-07-25 | “CHMP has recommended the refusal of the marketing authorization for pridopidine’s marketing authorization application for Huntington’s disease (HD).” prilenia.com ↗ “recommended against accepting the marketing authorization application for pridopidine for Huntington's disease (HD).” ferrer.com ↗ |
| Filed | EU (EMA) | — | Huntington disease | 2025-04-28 | “Pridopidine is currently being evaluated by the European Medicines Agency (EMA), which has accepted the submission of the marketing authorization application for the treatment...” ferrer.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03019289 | Apr 2017 → Feb 2018 | Huntington disease | Prilenia | Completed | No outcome recorded |
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT03922711 | May 2019 → Jul 2020 | Parkinson disease | Prilenia | Terminated | No outcome recorded |
| Phase 2 | NCT02494778 | Sep 2015 → Jan 2018 | Huntington disease | Prilenia | Terminated | No outcome recorded |
| Phase 2 | NCT02006472 | Feb 2014 → Dec 2015 | Huntington disease | Prilenia | Completed | Missed primary |
| Phase 2 | NCT01306929 | Mar 2011 → Jan 2018 | Huntington disease | Prilenia | Completed | No outcome recorded |
| Phase 2 | NCT00724048 | Oct 2008 → Jul 2010 | Huntington disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Missed primary |
| Phase 2/32 trials · 2 missed | ||||||
| Phase 2/3 | NCT04615923 | Dec 2020 → Jul 2022 | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Completed | Missed primary |
| Phase 2/3 | NCT04297683 | Jun 2020 → Jul 2027 expected | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Recruiting | Missed primary |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT07609108 | Jul 2026 → Jun 2028 expected | Huntington disease | Prilenia | Recruiting | No outcome recorded |
| Phase 3 | NCT07322003 | Feb 2026 → Mar 2028 expected | amyotrophic lateral sclerosis | Prilenia | Recruiting | No outcome recorded |
| Phase 3 | NCT04556656 | Oct 2020 → Mar 2023 | Huntington disease | Prilenia | Completed | Missed primary |
| Phase 3 | NCT00665223 | Apr 2008 → Jun 2010 | Huntington disease | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT06069934 | — | amyotrophic lateral sclerosis | Prilenia | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-12-11 | Prilenia | Regulatory Prilenia and Ferrer Announce FDA Clearance to Start the “PREVAiLS” Pivotal Phase 3 Study with Pridopidine in ALS prilenia.com ↗ |
| 2025-10-10 | Prilenia | Results Prilenia and Ferrer to Share New Data and Analyses of Pridopidine’s Impact on Huntington’s Disease at the Huntington Study Group (HSG) Congress prilenia.com ↗
Data demonstrates significant and clinically meaningful slowing of progression and significantly less decline across multiple endpoints of function, cognition and motor features in pridopidine-treated patients compared to both placebo and propensity-matched natural history cohorts including Track-HD and Enroll-HD |
| 2025-09-05 | Ferrer Internacional S.A. | Results Nature Medicine publishes phase 3 data on pridopidine in early-stage Huntington's disease ferrer.com ↗
The publication describes data showing that pridopidine treatment slowed clinical progression in patients with Huntington's disease (HD) who were not taking antidopaminergic drugs (ADMs). |
| 2025-09-05 | Prilenia | Results Nature Medicine Publishes Phase 3 Data on Pridopidine in Early-Stage Huntington’s Disease, Highlighting Impact on Clinical Progression prilenia.com ↗
The publication describes data showing that treatment with pridopidine slowed clinical progression in Huntington’s disease (HD) patients not taking antidopaminergic medicines (ADMs). |
| 2025-07-25 | Ferrer Internacional S.A. | Regulatory Prilenia and Ferrer report on the European regulatory process for pridopidine for Huntington's disease ferrer.com ↗
Prilenia Therapeutics B.V. and Ferrer announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against accepting the marketing authorization application for pridopidine for Huntington's disease (HD). |
| 2025-07-25 | Prilenia | Regulatory Prilenia and Ferrer Provide Update on European Regulatory Process for Pridopidine in Huntington’s Disease prilenia.com ↗
Prilenia Therapeutics B.V. and Ferrer today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorization for pridopidine’s marketing authorization application for Huntington’s disease (HD). |
| 2024-11-05 | Prilenia | Results Prilenia to Present Pridopidine Data at the Huntington Study Group (HSG) 2024 Congress prilenia.com ↗ |
| 2024-09-03 | Prilenia | Regulatory Prilenia’s Pridopidine for Huntington’s Disease Accepted for European Marketing Authorisation Review prilenia.com ↗ |
| 2024-04-12 | Prilenia | Results Prilenia to Present Latest Research from its Pridopidine Programs for Huntington Disease and ALS at AAN 2024 prilenia.com ↗ |
| 2023-04-25 | Prilenia | Results Prilenia Shares Preliminary Topline Results from Phase 3 PROOF-HD Clinical Trial in Huntington’s Disease and Data from Phase 2 HEALEY ALS Platform Trial of Pridopidine at the 75th American Academy of Neurology (AAN) Annual Meeting prilenia.com ↗
PROOF-HD primary endpoint (Unified Huntington Disease Rating Scale-Total Functional Capacity) and the key secondary endpoint (Composite Unified Huntington’s Disease Rating Scale) did not reach statistical significance |
| 2023-02-23 | Prilenia | Results Prilenia Announces Topline Results for Pridopidine in Phase 2 ALS Study prilenia.com ↗
Prilenia Therapeutics B.V. , a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative and neurodevelopmental disorders, today announced initial results from the pridopidine arm of the Phase 2 HEALEY ALS Platform Trial. |
| 2021-11-17 | Prilenia | Regulatory Prilenia Receives Fast Track Designation for Pridopidine for the Treatment of Huntington’s Disease prilenia.com ↗
Prilenia Therapeutics B.V. , a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD). |
| 2021-07-12 | Prilenia | Regulatory Prilenia: FDA Grants Orphan Drug Designation for pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS) prilenia.com ↗
FDA Grants Orphan Drug Designation for pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS) |
| 2021-06-29 | Prilenia | Regulatory Prilenia receives positive EMA opinion on Orphan Drug Designation for pridopidine in ALS prilenia.com ↗
Prilenia Therapeutics B.V. , a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, received a positive opinion on European Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis (ALS) . |
| 2018-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Data Across Multiple Therapeutic Areas at 70th Annual Meeting of the American Academy of Neurology tevapharm.com ↗
Pridopidine Treatment Recovers Gait Abnormalities and Rescues Impaired BDNF Expression in a Rett Syndrome Mouse Model |
| 2016-09-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Results from Exploratory 52-Week Phase 2 PRIDE-HD Study of Pridopidine in Huntington Disease tevapharm.com ↗
This study showed a statistically significant impact on the endpoint of disease progression at 52 weeks following treatment with pridopidine at certain doses versus placebo, as measured by TFC. |
All press releases naming this drug 29 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pridopidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01306929 ↗ |
| Known as | ACR-16 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | ACR16 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00665223 ↗ |
| Known as | ACR16 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | ASP-2314 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | ASP-2314 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | FR-310826 | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | Huntexil | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | Pridopidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | PRIDOPIDINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL596802 ↗ |
| Known as | TV-7820 | “Pridopidine (TV-7820) capsules” NCT03019289 ↗ |
| Action | Activate | “Pridopidine's activation of S1R enhances cellular processes that are crucial for neuronal function and survival but are impaired in neurodegenerative diseases.” PMID 36811812 ↗ Feb 2023 |
| Modality | Small molecule | — CHEMBL596802 ↗ |
| Route | Oral | “Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks.” NCT00665223 ↗ |
| Target | DRD2 | “Dopamine D2 receptor modulator” CHEMBL596802 ↗ |