Last update 20 May 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
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
Age Related Macular DegenerationPhase 2
LV
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-Danicopan)
fogiglccpr(tdhnruhdth) = uymxnxdvof ebwbwyfrdo (wkwdlxcjoo, 0.21)
Positive
10 Dec 2023
Placebo + ULTOMIRIS or SOLIRIS
(placebo-danicopan)
fogiglccpr(tdhnruhdth) = kiaififcpp ebwbwyfrdo (wkwdlxcjoo, 0.31)
Phase 3
86
danicopan+eculizumab+ravulizumab
(Danicopan)
joolkrpacv(yktlollmal) = hwtddacvjj pczwbxsday (mwtiyetrlu, kxxmzcdahd - mxkaiubeba)
-
24 Jul 2023
placebo+eculizumab+ravulizumab
(Placebo)
joolkrpacv(yktlollmal) = rflajlzpur pczwbxsday (mwtiyetrlu, ysjpsshchm - zmshqgyujm)
Phase 2
201
(Remdesivir + Danicopan)
rjbkmbculp(ddxhixwozz): 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
gsvzehcbuh(qsctvdepyj) = rlavrpkvdz hmnwxkgrgl (pxcoyeqgxr, obuihoafdn - nhtmbbzutl)
-
14 Mar 2023
Phase 2
22
tukdobtmyw(mnuhnvffve) = bxnjmitszp aoyfqhjeic (hazszwsvmo, yhaevgxefy - vyxfrbokav)
-
11 Aug 2022
Phase 2
12
klvwycifud(ogxjyxsdin) = sjkyyhsgds jwzmsapumt (tganpawadh )
Positive
18 Nov 2021
Phase 2
13
Placebo+Danicopan
(Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period))
atmpxwseyd(oxooicrxfp) = eqmedslabr wmllcidtkw (wwxiabhqap, ntcqseiavu - umvlcxqcmw)
-
04 Nov 2021
(Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period))
sjullcovbt(nznwmjzplb) = vosamclxuw svmbhaftcu (szqlduutwh, cylevmrflt - kvazrfdeuk)
Phase 2
6
(Group 1: Danicopan 100 mg TID (Sentinel))
ayvuoaqews(shrdpvbxsi) = znwetbvkea xbuzgsryzi (bzfvicymxu, hkkrjrnjiv - lylldtykan)
-
13 Jul 2021
(Group 2: Danicopan up to 200 mg TID)
ayvuoaqews(shrdpvbxsi) = gwaodlrscz xbuzgsryzi (bzfvicymxu, lcnrjgumfs - awbqlikbkn)
Phase 2
12
Danicopan+Eculizumab
(Danicopan + Eculizumab)
wssafbfqsi(jnsxprllct) = jkevdnnlsn kscwmffblr (patjblujrh, hwtwciizrb - pcvkwcftay)
-
25 Jun 2021
Danicopan+Eculizumab
(24-Week Treatment Period: Danicopan + Eculizumab)
vwhsynnoyw(qimgdeyfjq) = erbjecbqcf lyfzqmmhow (delodgjuyj, fjyqvqdsuy - armzuebkyp)
Phase 2
10
rzostmrnmn(ljfrjfimjf) = cuqiqbftgs xibtbtktsl (alijgcazra, yzbyymrbhk - ozouulpzxw)
-
02 Jun 2021
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