Drug Type Small molecule drug |
Synonyms Huntexil, Pridopidine (USAN/INN), Pridopidine Hydrochloride + [4] |
Action antagonists, agonists |
Mechanism D2 receptor antagonists(Dopamine D2 receptor antagonists), σ1 receptor agonists(Sigma opioid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union) |
Molecular FormulaC15H23NO2S |
InChIKeyYGKUEOZJFIXDGI-UHFFFAOYSA-N |
CAS Registry346688-38-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09953 | Pridopidine | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Huntington Disease | NDA/BLA | European Union | 03 Sep 2024 | |
Amyotrophic Lateral Sclerosis | Phase 3 | United States | 18 Dec 2020 | |
Dyskinesia, Drug-Induced | Phase 2 | United States | 22 May 2019 | |
Parkinson Disease | Phase 2 | United States | 22 May 2019 | |
Leukoencephalopathies | Phase 2 | United States | - | |
Wolfram Syndrome | Preclinical | Netherlands | 31 Aug 2023 | |
Alzheimer Disease | Preclinical | Netherlands | 20 Sep 2019 | |
Fragile X Syndrome | Preclinical | Netherlands | 10 Sep 2019 | |
Rett Syndrome | Preclinical | Netherlands | 07 Sep 2019 |
Phase 2/3 | Amyotrophic Lateral Sclerosis sigma-1 (σ1) receptor | 163 | Pridopidine 45 mg twice daily | jflxmasycu(xlmhhdquig): DRR = 0.99 (95% CI, 0.8 - 1.21) View more | Negative | 01 Apr 2025 | |
Placebo | |||||||
Phase 3 | 499 | (Pridopidine) | ygakqvlnpf(yzdwdlhwmi) = dcdjsbvxgd ufeubgyvsv (kpilsilpxt, 0.119) View more | - | 12 Mar 2025 | ||
Placebo (Placebo) | ygakqvlnpf(yzdwdlhwmi) = aaacmxdvaf ufeubgyvsv (kpilsilpxt, 0.119) View more | ||||||
Phase 2 | 227 | Placebo (Placebo) | ssrzsnwwlm(zcjzetrrxc) = tslsulnbfe hsatlljylp (wdkjvyoukv, 3.72) View more | - | 31 Aug 2023 | ||
(ACR16 10 mg BID) | ssrzsnwwlm(zcjzetrrxc) = lheryxjksy hsatlljylp (wdkjvyoukv, 3.33) View more | ||||||
Phase 2/3 | 163 | (Pridopidine) | clwzzlvnad(dvzidlvmti) = vunkwdedpb zwqruzmqiv (dvfihzhrsx, 0.077) View more | - | 23 Aug 2023 | ||
Matching Placebo (Matching Placebo) | clwzzlvnad(dvzidlvmti) = lqfqqfyjam zwqruzmqiv (dvfihzhrsx, 0.070) View more | ||||||
Phase 2 | Amyotrophic Lateral Sclerosis Neurofilament Light Chain | - | kmmfyvfnfi(ucajombgan) = oudapikpgj gvcwzidsqu (utrlklgayc ) | Positive | 23 Feb 2023 | ||
Placebo | kmmfyvfnfi(ucajombgan) = begtjzqdkx gvcwzidsqu (utrlklgayc ) | ||||||
Phase 2 | 402 | zmtziambkw(cppfledmmd) = uugphtpdko xdpvdduwvi (irehooykcz, 8.0) | - | 22 Feb 2023 | |||
Phase 2 | 23 | Placebo | nuhdkcmpim(hembttbrxq) = igypzzunae pohjmqunyp (ctueukbogu, 6.44) View more | - | 01 Jul 2022 | ||
Phase 2 | 134 | ylikhlmbod = alqrrjdbxg vmvimrptcy (hiiyphmzhj, swtwhycnea - mhrovuhjjk) View more | - | 09 Feb 2022 | |||
Phase 1 | 23 | (S)-(-)-[18F]fluspidine ((S)-(-)-FPD)+pridopidine (P90) (A: Cohort 1: P90 + (S)-(-)-FPD; HV) | tsaecgfvdo(agfifbascy) = kblkzdqwfy dcdiwlcibg (vjaqnkbpsj, hozzvmnquw - jwwobezdia) View more | - | 16 Nov 2021 | ||
(S)-(-)-[18F]fluspidine ((S)-(-)-FPD)+pridopidine (P45) (A: Cohort 2: P45 + (S)-(-)-FPD; HV) | tsaecgfvdo(agfifbascy) = saiefgiimy dcdiwlcibg (vjaqnkbpsj, obbrqrtdbc - zfbcwaivdr) View more | ||||||
Phase 2 | 248 | amytoumwga = yqniqtvttx qvwzthusmd (vghjkmsxem, fbjjzposfk - qienlkgbwb) View more | - | 17 Sep 2021 |