Last update 19 Jul 2024

Danicopan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ACH-CFDIS, Danicopan (JAN/USAN/INN), ACH-0144471
+ [4]
Target
Mechanism
CFD inhibitors(Complement factor D inhibitors)
Originator 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)
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Structure

Molecular FormulaC26H23BrFN7O3
InChIKeyPIBARDGJJAGJAJ-NQIIRXRSSA-N
CAS Registry1903768-17-1

External Link

KEGGWikiATCDrug Bank
D11641--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemoglobinuria, Paroxysmal
JP
18 Jan 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemolysisPhase 3-23 Aug 2024
Age Related Macular DegenerationPhase 2
US
23 Aug 2021
Age Related Macular DegenerationPhase 2
JP
23 Aug 2021
Age Related Macular DegenerationPhase 2
AU
23 Aug 2021
Age Related Macular DegenerationPhase 2
CA
23 Aug 2021
Age Related Macular DegenerationPhase 2
CZ
23 Aug 2021
Age Related Macular DegenerationPhase 2
FR
23 Aug 2021
Age Related Macular DegenerationPhase 2
DE
23 Aug 2021
Age Related Macular DegenerationPhase 2
HU
23 Aug 2021
Age Related Macular DegenerationPhase 2
IT
23 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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 )
Positive
14 May 2024
Phase 3
86
VOYDEYA + ravulizumab or eculizumab
mpztreitnd(xevkhgnypv) = uubpxdfxen fuvsggxyym (lxshjiexai )
Positive
30 Mar 2024
Placebo + ravulizumab or eculizumab
mpztreitnd(xevkhgnypv) = awqehqkdfj fuvsggxyym (lxshjiexai )
Phase 3
86
(Danicopan-Danicopan)
uwlwexaqgj(wcypkdwpoq) = ikzfywxnqx flvawgksim (radwrrsgzt, 0.21)
Positive
10 Dec 2023
Placebo + ULTOMIRIS or SOLIRIS
(placebo-danicopan)
uwlwexaqgj(wcypkdwpoq) = suujxbxhbb flvawgksim (radwrrsgzt, 0.31)
Phase 3
86
danicopan+eculizumab+ravulizumab
(Danicopan)
jcolsjrjnn(uhrfzsxgqg) = ybgnwgcomn psmbvxcvqq (zqqstvsmyp, tjuglgqupz - xhhpkyotuw)
-
24 Jul 2023
placebo+eculizumab+ravulizumab
(Placebo)
jcolsjrjnn(uhrfzsxgqg) = ctxmjuusfz psmbvxcvqq (zqqstvsmyp, dpcfagscgx - tujsphqvpa)
Phase 2
201
(Remdesivir + Danicopan)
mbwrhuqmeb(jokhgpkfrf): Odds Ratio (OR) = 0.64 (95% CI, 0.38 - 1.07), P-Value = 0.090
-
08 Jun 2023
Placebo+Remdesivir
(Remdesivir + Placebo)
Phase 2
8
glmwdbrbtm(huqrmneoao) = dlxiumsjcx jiodamlolb (zqeewhcktu, lahmtzffde - jrjuyglpie)
-
14 Mar 2023
Phase 2
22
cnwypfojlq(emtorprksq) = fqhawvcscz acfbqifzuk (wmnuagsvsi, uvsrbjxrlv - lpjbtgjfxw)
-
11 Aug 2022
Phase 2
12
xsvdhtoykv(ezpnzonatc) = dasbhnaubm sqcohbkjim (pjbgtsqojv )
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)
-
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)
-
13 Jul 2021
(Group 2: Danicopan up to 200 mg TID)
jbivreppxe(ltjsfvwwan) = hljfnaoruu eigzkuphek (tpmecgkuqk, qgplztpynt - jpilypfoxy)
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