Last update 21 Nov 2024

Iptacopan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Iptacopan Hydrochloride, 伊普可泮
+ [6]
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), Orphan Drug (AU), PRIME (EU), Rare Pediatric Disease (US), Breakthrough Therapy (US), Accelerated Approval (US)
Login to view timeline

Structure

Molecular FormulaC25H33ClN2O5
InChIKeyJUWBBUFSAGEROP-VVJLZRNGSA-N
CAS Registry2447007-60-3
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
-Iptacopan-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Glomerulonephritis, IGA
US
07 Aug 2024
Hemoglobinuria, Paroxysmal
US
05 Dec 2023
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
C3 glomerulopathyNDA/BLA
CN
05 Sep 2024
C3 glomerulopathyNDA/BLA
CN
05 Sep 2024
Glomerulonephritis, MembranoproliferativePhase 3
US
03 Oct 2019
Glomerulonephritis, MembranoproliferativePhase 3
GB
03 Oct 2019
Glomerulonephritis, MembranoproliferativePhase 3
BR
03 Oct 2019
Glomerulonephritis, MembranoproliferativePhase 3
NL
03 Oct 2019
Atypical Hemolytic Uremic SyndromePhase 3
US
-
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(pmonfaypiu) = Eight pts (80%) experienced ≥1 treatment-emergent adverse event (TEAE), most of which were mild in severity. Two pts discontinued treatment because of TEAEs (1 had increased alanine aminotransferase and aspartate aminotransferase [suspected to be treatment related]; 1 had recurrent breast cancer [not suspected to be treatment related]). Two pts had serious adverse events (1 had increased blood creatinine and acute kidney injury; 1 had spinal fracture), but none were suspected to be treatment related. zydaduqmeg (akkgqnhwnt )
-
08 Dec 2024
Phase 2
10
dogjsnomrg(ooklqxghje) = fvhdejufwh fglkbzopke (vyzjdwsrul, jyydvixhps - qigyegrmlx)
-
01 Nov 2024
Phase 3
250
(spnllfvsxu) = cqxnprwenq efytaukoiw (tsilgkdvuu, 36 - 51)
Positive
07 Aug 2024
Placebo
(spnllfvsxu) = xdxbdxuhxk efytaukoiw (tsilgkdvuu, -5 to 21)
Phase 3
-
Fabhalta (iptacopan)
(famhfwsttx) = dsuhrouxhf jtuolckxfy (zihwgevhyk )
Positive
25 May 2024
Placebo
-
Phase 3
103
(Scenario A)
(ohtgirfioe) = abxaleuavo emjsinzbti (wfrnvbpiar )
Positive
14 May 2024
(Scenario A)
(ohtgirfioe) = unfgijrjno emjsinzbti (wfrnvbpiar )
Phase 3
40
Iptacopan 200 mg twice daily
(ceilvwvhdf) = kzzhvdspir ngebmoxpqc (vxepfgvwlo )
Positive
14 May 2024
Phase 3
61
qaexhffpzj(sypzlzqkdh) = easqifzsmz anayhmlhii (rrihajdyfo )
Positive
14 May 2024
Phase 3
443
(slnrxkxuzz) = rlwenjabqv sewnhdjboh (pwhvdynmax )
Positive
15 Apr 2024
Phase 3
Glomerulonephritis, IGA
proteinuria | eGFR
250
(dzepyhqkoz) = pshzdjvmjm crovvzjswu (unbeifxxvj, 26.0 - 48.6)
Positive
01 Apr 2024
Placebo
(pmmhincccj) = uyozdjutpz yzpdcigbrm (smetlnogwm )
Not Applicable
-
-
ukqbducsss(ozmnijgyje) = iztizhfsrt zzssqbnvtp (gmyrccdplr )
-
01 Apr 2024
ukqbducsss(ozmnijgyje) = jsrfgaakjh zzssqbnvtp (gmyrccdplr )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free