Asunaprevir

Summary

Asunaprevir (CHEMBL2105735) is an approved small molecule (ATC J05AP06); indicated across 4 conditions including viral infectious disease and hepatitis c virus infection.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AP06
• Indications: 4 conditions
• Clinical trials: 28
• Chemistry: 748.3 Da · C35H46ClN5O9S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2105735
Name	Asunaprevir
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	16076883
ATC	J05AP06
Molecular formula	C35H46ClN5O9S
Molecular weight	748.3
InChIKey	XRWSZZJLZRKHHD-WVWIJVSJSA-N

SMILES: CC(C)(C)[C@@H](C(=O)N1C[C@@H](C[C@H]1C(=O)N[C@@]2(C[C@H]2C=C)C(=O)NS(=O)(=O)C3CC3)OC4=NC=C(C5=C4C=C(C=C5)Cl)OC)NC(=O)OC(C)(C)C

IUPAC name: tert-butyl N-[(2S)-1-[(2S,4R)-4-(7-chloro-4-methoxyisoquinolin-1-yl)oxy-2-[[(1R,2S)-1-(cyclopropylsulfonylcarbamoyl)-2-ethenylcyclopropyl]carbamoyl]pyrrolidin-1-yl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate

Also known as: Asunaprevir, BMS 650032, BMS-650032, BMS650032, Sunvepra, ASUNAPREVIR, asunaprevir

Patent coverage: 338 distinct patent families (793 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 690 (87%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
viral infectious disease	4	MONDO:0005108	EFO:0000763
hepatitis C virus infection	3	MONDO:0005231	EFO:0003047
chronic hepatitis C virus infection	3	MONDO:0005354	EFO:0004220

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 28.

Phase distribution

Phase	Trials
PHASE3	10
PHASE2	9
PHASE1	5
Not specified	3
PHASE4	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02639585	PHASE4	UNKNOWN	Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C
NCT01497834	PHASE3	COMPLETED	A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
NCT01573351	PHASE3	COMPLETED	Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
NCT01581203	PHASE3	COMPLETED	Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
NCT01718145	PHASE3	COMPLETED	A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
NCT01973049	PHASE3	COMPLETED	UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
NCT01995266	PHASE3	COMPLETED	Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
NCT02123654	PHASE3	COMPLETED	UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
NCT02282709	PHASE3	COMPLETED	Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
NCT02496078	PHASE3	COMPLETED	A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
NCT03004625	PHASE3	COMPLETED	Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV
NCT00722358	PHASE2	COMPLETED	A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
NCT01012895	PHASE2	COMPLETED	Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
NCT01030432	PHASE2	COMPLETED	Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
NCT01051414	PHASE2	COMPLETED	An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
NCT01309932	PHASE2	COMPLETED	Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
NCT01428063	PHASE2	COMPLETED	Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
NCT01455090	PHASE2	COMPLETED	Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
NCT02107365	PHASE2	COMPLETED	Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)
NCT02124044	PHASE2	COMPLETED	Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
NCT00904059	PHASE1	COMPLETED	Drug-Drug Interaction Study in Healthy Subjects
NCT01019070	PHASE1	COMPLETED	Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
NCT01063023	PHASE1	COMPLETED	Drug Interaction Oral Contraceptive Pill (OCP)
NCT01886599	PHASE1	COMPLETED	Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
NCT02323594	PHASE1	COMPLETED	A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
NCT01492504	Not specified	COMPLETED	Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
NCT02762448	Not specified	WITHDRAWN	Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas
NCT02865369	Not specified	UNKNOWN	Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 1 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).