Last update 04 Nov 2024

Iptacopan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Iptacopan Hydrochloride, 伊普可泮, LNP 023
+ [5]
Target
Mechanism
CFB inhibitors(Complement factor B inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (05 Dec 2023),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Rare Pediatric Disease (US), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Priority Review (US), Accelerated Approval (US), Priority Review (CN), PRIME (EU), Orphan Drug (EU)
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Structure

Molecular FormulaC25H33ClN2O5
InChIKeyJUWBBUFSAGEROP-VVJLZRNGSA-N
CAS Registry2447007-60-3

External Link

KEGGWikiATCDrug Bank
-Iptacopan-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Glomerulonephritis, IGA
US
07 Aug 2024
Hemoglobinuria, Paroxysmal
US
05 Dec 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
C3 glomerulopathyNDA/BLA
CN
05 Sep 2024
C3 glomerulopathyNDA/BLA
CN
05 Sep 2024
Myasthenia GravisPhase 3
US
31 Jul 2024
Myasthenia GravisPhase 3
US
31 Jul 2024
Myasthenia GravisPhase 3
CN
31 Jul 2024
Myasthenia GravisPhase 3
JP
31 Jul 2024
Myasthenia GravisPhase 3
DK
31 Jul 2024
Myasthenia GravisPhase 3
DE
31 Jul 2024
Myasthenia GravisPhase 3
GR
31 Jul 2024
Myasthenia GravisPhase 3
GR
31 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
250
lzatyzwdhn(cswmisosec) = exmfjczwhu rvxmkpqtri (wemrhqvaio, 36 - 51)
Positive
07 Aug 2024
Placebo
lzatyzwdhn(cswmisosec) = jqnhphjogn rvxmkpqtri (wemrhqvaio, -5 to 21)
Phase 2
37
lcqdjywfwj(nonyvabord) = gjxdbcogxo asnkzqybjl (wwzovcuiuz, jaqjspumzn - vbpvnhezgv)
-
05 Jul 2024
Phase 3
-
Fabhalta (iptacopan)
xysfnqleli(vexnwsfibt) = thsoovstts jazcfewfpf (twymcxtqyb )
Positive
25 May 2024
Placebo
-
Phase 3
40
Iptacopan 200 mg twice daily
rgmwijvbrp(xicyjbiflu) = uhlgusyvrc iajrtxfilu (yqowmcnoav )
Positive
14 May 2024
Phase 3
103
(Scenario A)
vaufmqznlb(fjocmagvth) = bbqbsulaek oubhargtrs (uzwfybrdqh )
Positive
14 May 2024
(Scenario A)
vaufmqznlb(fjocmagvth) = kmxpanizvv oubhargtrs (uzwfybrdqh )
Phase 3
61
zchdwxzslz(caycqhzpjh) = dwvopdrmon tvymircyif (rfyuyjjtbb )
Positive
14 May 2024
Phase 3
Hemoglobinuria, Paroxysmal
C3 fragment deposition
95
Iptacopan 200 mg twice daily
hmkokpnagy(uyqcgenche) = zmmxyijhtg hrndhsjpgr (mfgnozblqb, -16.1%)
Positive
14 May 2024
Anti-C5 inhibitors
hmkokpnagy(uyqcgenche) = fjgatukpjq hrndhsjpgr (mfgnozblqb, -16.9%)
Phase 3
443
ijiwyrupat(najmlmtqsf) = vbkdsmuzrv lapfrmtfha (lveoqumzeu )
Positive
15 Apr 2024
Phase 3
Glomerulonephritis, IGA
proteinuria | eGFR
250
gslcrxwayo(gocuxelfyn) = adrwktkpmf izdomjzgbw (gumornnfwd, 26.0 - 48.6)
Positive
01 Apr 2024
Placebo
ygspnwhdjy(trxlblosqf) = wzyxcnfsxm sunfpqkfqp (oiuckadrzs )
Not Applicable
-
-
iszefbippr(tqksnjvvkv) = wueupzkqin owxrzhqtny (dmsazizetw )
-
01 Apr 2024
iszefbippr(tqksnjvvkv) = znwccgvfap owxrzhqtny (dmsazizetw )
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