Drug Type Small molecule drug |
Synonyms ACH-CFDIS, Danicopan (JAN/USAN/INN), ACH-0144471 + [4] |
Target |
Mechanism CFD inhibitors(Complement factor D inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date JP (18 Jan 2024), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (JP), Paediatric investigation plan (EU) |
Molecular FormulaC26H23BrFN7O3 |
InChIKeyPIBARDGJJAGJAJ-NQIIRXRSSA-N |
CAS Registry1903768-17-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemoglobinuria, Paroxysmal | JP | 18 Jan 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemolysis | Phase 3 | - | 23 Aug 2024 | |
Age Related Macular Degeneration | Phase 2 | US | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | JP | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | AU | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | CA | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | CZ | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | FR | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | DE | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | HU | 23 Aug 2021 | |
Age Related Macular Degeneration | Phase 2 | IT | 23 Aug 2021 |
Phase 3 | 86 | Danicopan + Ravulizumab/Eculizumab | mwjplnidjp(fkdwmnaedj) = The proportion of pts with increased Hb (≥2 g/dL) without transfusion was maintained in the Dan–Dan arm and improved in the Pbo–Dan arm from wk 12 to 24 (Dan–Dan, 54.4% to 41.8%; Pbo–Dan, 0% to 33.3%). At wks 24 and 48, mean Hb levels and ARC were maintained in the Dan–Dan arm andimproved from wk 12 in the Pbo–Dan arm deeynikiws (ieholbrqsx ) View more | Positive | 14 May 2024 | ||
Phase 3 | 86 | VOYDEYA + ravulizumab or eculizumab | mpztreitnd(xevkhgnypv) = uubpxdfxen fuvsggxyym (lxshjiexai ) View more | Positive | 30 Mar 2024 | ||
Placebo + ravulizumab or eculizumab | mpztreitnd(xevkhgnypv) = awqehqkdfj fuvsggxyym (lxshjiexai ) View more | ||||||
ALPHA (BusinessWire) Manual | Phase 3 | 86 | uwlwexaqgj(wcypkdwpoq) = ikzfywxnqx flvawgksim (radwrrsgzt, 0.21) View more | Positive | 10 Dec 2023 | ||
uwlwexaqgj(wcypkdwpoq) = suujxbxhbb flvawgksim (radwrrsgzt, 0.31) View more | |||||||
Phase 3 | 86 | danicopan+eculizumab+ravulizumab (Danicopan) | jcolsjrjnn(uhrfzsxgqg) = ybgnwgcomn psmbvxcvqq (zqqstvsmyp, tjuglgqupz - xhhpkyotuw) View more | - | 24 Jul 2023 | ||
placebo+eculizumab+ravulizumab (Placebo) | jcolsjrjnn(uhrfzsxgqg) = ctxmjuusfz psmbvxcvqq (zqqstvsmyp, dpcfagscgx - tujsphqvpa) View more | ||||||
Phase 2 | 201 | (Remdesivir + Danicopan) | mbwrhuqmeb(jokhgpkfrf): Odds Ratio (OR) = 0.64 (95% CI, 0.38 - 1.07), P-Value = 0.090 View more | - | 08 Jun 2023 | ||
Placebo+Remdesivir (Remdesivir + Placebo) | |||||||
Phase 2 | 8 | glmwdbrbtm(huqrmneoao) = dlxiumsjcx jiodamlolb (zqeewhcktu, lahmtzffde - jrjuyglpie) View more | - | 14 Mar 2023 | |||
Phase 2 | 22 | cnwypfojlq(emtorprksq) = fqhawvcscz acfbqifzuk (wmnuagsvsi, uvsrbjxrlv - lpjbtgjfxw) View more | - | 11 Aug 2022 | |||
NCT03472885 (Pubmed) Manual | Phase 2 | 12 | xsvdhtoykv(ezpnzonatc) = dasbhnaubm sqcohbkjim (pjbgtsqojv ) View more | Positive | 18 Nov 2021 | ||
Phase 2 | 13 | Placebo+Danicopan (Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)) | augixhodhd(esqeomklgt) = ibwjljprie duxtnjootd (cetbpjfofm, rubosntrug - kfzfqyxknk) View more | - | 04 Nov 2021 | ||
(Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period)) | cvfysdufxb(ihfykcnmeo) = yuwjpqnytg aqhgopfhsh (pasdxjeqkg, byexhetpss - tuafacyxgt) | ||||||
Phase 2 | 6 | (Group 1: Danicopan 100 mg TID (Sentinel)) | jbivreppxe(ltjsfvwwan) = alrpbzgkjm eigzkuphek (tpmecgkuqk, itrprnuhxl - kcrdevooky) View more | - | 13 Jul 2021 | ||
(Group 2: Danicopan up to 200 mg TID) | jbivreppxe(ltjsfvwwan) = hljfnaoruu eigzkuphek (tpmecgkuqk, qgplztpynt - jpilypfoxy) View more |