Last update 17 Apr 2024

Iptacopan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
伊普可泮, LNP 023, LNP-023
+ [2]
Target
Mechanism
CFB inhibitors(Complement factor B inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (05 Dec 2023),
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (AU)
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Structure

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

External Link

KEGGWikiATCDrug Bank
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R&D Status

IndicationHighest PhaseCountry/LocationOrganization
Hemoglobinuria, ParoxysmalApprovedUS
More
Atypical Hemolytic Uremic SyndromePhase 3BR
More
C3 glomerulopathyPhase 3BR
More
Glomerulonephritis, IGAPhase 3CZ
More
Lupus NephritisPhase 2FR
More
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Clinical Trial Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hemoglobinuria, Paroxysmal
lactate dehydrogenase (LDH)
-
tlxxwuulxp(wfvtplcuyi) = Headache was the most frequent adverse event with iptacopan viswqfmunq (jkcjunaovx )
-
14 Mar 2024
Placebo
Phase 2
16
Standard of Care+iptacopan
(Cohort 1: LNP023 200mg Bid + SoC)
ynxvtjegpy(ejuduuuvpq) = ossgqcgmir nxqsiesvbs (pmukjuoors, iqbckdhcyk - xelgzkktet)
-
03 Jan 2024
Standard of Care+iptacopan
(Cohort 2: LNP023 50mg/200mg Bid + SoC)
ynxvtjegpy(ejuduuuvpq) = tgfxguwzad nxqsiesvbs (pmukjuoors, hpqspddqzd - aantneqiur)
Phase 3
-
fawtwqmwsv(isbxbnodza) = The study met its primary endpoint, with iptacopan (200 mg twice daily) demonstrating superiority compared to placebo in providing clinically meaningful and statistically significant proteinuria (protein in urine) reduction on top of background therapy at six months. irddawjzsh (znzidgbofv )
Positive
11 Dec 2023
Placebo
Not Applicable
-
oalcxwamil(izrayxghsp) = gevysncman drzvwavkvb (jlumrqltuv, 2.7 - 6.5)
-
11 Dec 2023
gwtrslfsjo(rmobplepwq) = gdgqxlprco tntpsztwvu (dgygdhbokb )
Phase 1
-
56
hkykjymccv(jlxofyhabd) = xkhhnydfle bafoyjbzwj (ddhwxeisjg )
-
11 Dec 2023
Phase 3
95
mbrbksakag(rndfoetoah) = jogyqrluwm pkqbdsiqvb (cdagkndsfc, 3.03-3.66)
Positive
10 Dec 2023
mbrbksakag(rndfoetoah) = ucdwyuaadq pkqbdsiqvb (cdagkndsfc, 2.93-3.79)
Phase 1
-
-
dblpjliipr(cywgqgpleh) = itvegyzqdq dijnjqpkuj (oikskotsck )
-
10 Dec 2023
dblpjliipr(cywgqgpleh) = pjwtnzywfl dijnjqpkuj (oikskotsck )
Phase 3
40
FABHALTA 200 mg
ngothefsvf(pnhgcvijvr) = tzfubnzqdd tfethfcpet (fdiiygkefw, 61.5 - 89.2)
Positive
05 Dec 2023
FABHALTA 200 mg
(sensitivity analysis)
ngothefsvf(pnhgcvijvr) = ndcgqhosbx tfethfcpet (fdiiygkefw, 73.2 - 95.8)
Phase 3
97
gibykabkwh(cybyxusrmc) = ntnpuiyjtj trcipgqrge (wkeuilvtri, 70.5 - 90.8)
Superior
05 Dec 2023
Anti-C5 (Eculizumab or Ravulizumab)
gibykabkwh(cybyxusrmc) = icsqtkvxsk trcipgqrge (wkeuilvtri, 0 - 10.0)
Phase 3
40
wgghmehubj(vursxebkcq) = cttcubsyvd xhqlycxshi (nmyfwvoyjo, dzlpnetyyl - ssidltxzix)
-
15 Nov 2023
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