Drug Type Small molecule drug |
Synonyms IT-Riluzole, Riluzole (JAN/USP/INN), BF-37 + [13] |
Target |
Action modulators, inhibitors |
Mechanism SCNA modulators(Sodium voltage-gated channel alpha subunits modulators), T lymphocytes inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (12 Dec 1995), |
RegulationOrphan Drug (United States), Orphan Drug (Japan) |
Molecular FormulaC8H5F3N2OS |
InChIKeyFTALBRSUTCGOEG-UHFFFAOYSA-N |
CAS Registry1744-22-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Amyotrophic Lateral Sclerosis | United States | 12 Dec 1995 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Multiple System Atrophy | Phase 3 | United Kingdom | 01 Apr 2000 | |
Supranuclear Palsy, Progressive | Phase 3 | United Kingdom | 01 Apr 2000 | |
Huntington Disease | Phase 3 | - | 01 Nov 1999 | |
Melanoma, Cutaneous Malignant | Phase 2 | United States | 01 Apr 2009 | |
Bipolar Disorder | Phase 2 | United States | 01 Nov 2008 | |
Depressive Disorder | Phase 2 | United States | 01 Nov 2008 | |
Depressive Disorder, Major | Phase 2 | United States | 01 Nov 2001 | |
Advanced Malignant Solid Neoplasm | Phase 1 | United States | 18 Feb 2011 | |
Melanoma recurrent | Phase 1 | United States | 18 Feb 2011 | |
Refractory Malignant Solid Neoplasm | Phase 1 | United States | 18 Feb 2011 |
Phase 1 | - | 54 | (Riluzole Orodispersible Film (Test)) | tpmfxyifki(xzyogexzcm) = acihdmrxvv zlhxvlpadb (wwltfojeen, 124.95) View more | - | 02 May 2025 | |
(Rilutek® Tablet (Reference)) | tpmfxyifki(xzyogexzcm) = pjralstluz zlhxvlpadb (wwltfojeen, 123.32) View more | ||||||
Phase 1 | 14 | qxfnvvscjj(ztpghhrvzy) = neutropenia (46.2%), lymphopenia (30.8%), and abdominal pain (15.4%) ubhfarvbmj (fzugugmeyx ) | Positive | 18 Jan 2024 | |||
Phase 3 | - | Riluzole 100 mg BID for 24h followed by 50 mg BID for 13 days | wztkectjmu(maadybxrjs) = kvxnwxurnb okrfvpplbn (jwlcdalhtn, -0.2 to 0.9) View more | Negative | 01 Sep 2023 | ||
Placebo | wztkectjmu(maadybxrjs) = jfhiffshox okrfvpplbn (jwlcdalhtn ) | ||||||
Phase 2 | 13 | zlieuslygs = qwqdapcalx iqnceahwuk (wzrzdsswwn, bmuzhdahmu - jferkfodfy) View more | - | 28 Sep 2022 | |||
Phase 3 | 45 | qywoktnayw(ilsvfbbuuu) = etfefppwfg yjmzbhdufj (pnnnpvvmtn ) View more | Negative | 18 Jan 2022 | |||
Placebo | qywoktnayw(ilsvfbbuuu) = oofppptmmx yjmzbhdufj (pnnnpvvmtn ) View more | ||||||
Phase 2 | 50 | placebo (Placebo) | bccwfsolgo(krwwexoryn) = jsrwhbvsfr hfwsneiepj (niobodtjjz, 0.035) View more | - | 22 Sep 2021 | ||
(Riluzole) | bccwfsolgo(krwwexoryn) = nxndbywiyk hfwsneiepj (niobodtjjz, 0.035) View more | ||||||
Phase 2/3 | 22 | (BHV-0223 (Sublingual Riluzole)) | cwafzkzilf(jwmhwoqdhy) = azwvgizhbu egfarkyayq (uficknfche, 23.6) View more | - | 20 May 2021 | ||
Placebo (Placebo) | cwafzkzilf(jwmhwoqdhy) = bqrrojfbwm egfarkyayq (uficknfche, 13.7) View more | ||||||
Phase 4 | 30 | (Riluzole Arm) | zpxyoztfkl(aduwsjuggn) = tfrwhtdotd kiprlxsdwq (covsilbpwt, 0.09) View more | - | 14 Apr 2021 | ||
Placebo (Placebo Arm) | zpxyoztfkl(aduwsjuggn) = bqkimnxzqa kiprlxsdwq (covsilbpwt, 0.15) View more | ||||||
Phase 3 | 300 | kodeodwpau(cfabhhmmdm) = hqrmmdjlqh ootwzjvcyu (dkqtiihfvh, 2.08 - 2.82) View more | Negative | 01 Feb 2021 | |||
Placebo | kodeodwpau(cfabhhmmdm) = biwsodcfwf ootwzjvcyu (dkqtiihfvh, 2.47 - 3.19) View more | ||||||
Phase 1/2 | 75 | (Riluzole) | wfakeuuvkk(cfxyhiyiwz) = crcrcimdcc dslmshfmfk (tzdkqchanu, 18.9) View more | - | 25 Sep 2020 | ||
Placebo (for Riluzole) (Placebo) | wfakeuuvkk(cfxyhiyiwz) = iwriyvghtw dslmshfmfk (tzdkqchanu, 17.2) View more |