Danoprevir

Summary

Danoprevir (CHEMBL258734) is a phase-3 clinical-stage small molecule; indicated across 2 conditions including chronic hepatitis c virus infection and hepatitis c virus infection.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 2 conditions
• Clinical trials: 33
• Chemistry: 731.8 Da · C35H46FN5O9S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL258734
Name	Danoprevir
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	11285588
Molecular formula	C35H46FN5O9S
Molecular weight	731.8
InChIKey	ZVTDLPBHTSMEJZ-JSZLBQEHSA-N

SMILES: CC(C)(C)OC(=O)N[C@H]1CCCCC/C=C\[C@@H]2C[C@]2(NC(=O)[C@@H]3C[C@H](CN3C1=O)OC(=O)N4CC5=C(C4)C(=CC=C5)F)C(=O)NS(=O)(=O)C6CC6

IUPAC name: [(1S,4R,6S,7Z,14S,18R)-4-(cyclopropylsulfonylcarbamoyl)-14-[(2-methylpropan-2-yl)oxycarbonylamino]-2,15-dioxo-3,16-diazatricyclo[14.3.0.04,6]nonadec-7-en-18-yl] 4-fluoro-1,3-dihydroisoindole-2-carboxylate

Also known as: Danoprevir, R-05190591, R05190591, RO-5190591, RO5190591, DANOPREVIR, DANOPREVIR (ITMN-191), Danoprevir (ITMN-191)

Parent form; salt/anhydrous children: CHEMBL2146090

Patent coverage: 540 distinct patent families (1,256 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 1,000 (80%) 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

2 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
chronic hepatitis C virus infection	3	MONDO:0005354	EFO:0004220
hepatitis C virus infection	2	MONDO:0005231	EFO:0003047

Clinical trials

Total trials: 33.

Phase distribution

Phase	Trials
PHASE1	20
PHASE2	10
PHASE4	1
PHASE3	1
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04345276	PHASE4	COMPLETED	Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
NCT03020082	PHASE3	COMPLETED	Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
NCT03362814	PHASE2/PHASE3	COMPLETED	Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.
NCT00963885	PHASE2	COMPLETED	A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
NCT01220947	PHASE2	COMPLETED	A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
NCT01278134	PHASE2	COMPLETED	A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
NCT01331850	PHASE2	COMPLETED	A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
NCT01483742	PHASE2	COMPLETED	A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
NCT01579019	PHASE2	WITHDRAWN	A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
NCT01628094	PHASE2	COMPLETED	ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
NCT01749150	PHASE2	COMPLETED	A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
NCT03020004	PHASE2	COMPLETED	Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
NCT03020095	PHASE2	COMPLETED	Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan
NCT00801255	PHASE1	COMPLETED	A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients
NCT01164488	PHASE1	COMPLETED	A Study of RO5190591 (Danoprevir) in Healthy Volunteers
NCT01185860	PHASE1	COMPLETED	A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
NCT01185873	PHASE1	COMPLETED	A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
NCT01389544	PHASE1	COMPLETED	A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
NCT01392755	PHASE1	COMPLETED	A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
NCT01398293	PHASE1	COMPLETED	A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
NCT01418274	PHASE1	COMPLETED	A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
NCT01483729	PHASE1	COMPLETED	A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
NCT01514968	PHASE1	COMPLETED	A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
NCT01519336	PHASE1	COMPLETED	A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
NCT01531647	PHASE1	COMPLETED	A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
NCT01588002	PHASE1	COMPLETED	A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers
NCT01592305	PHASE1	COMPLETED	A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
NCT01592318	PHASE1	COMPLETED	A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
NCT01654211	PHASE1	COMPLETED	A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
NCT01714154	PHASE1	COMPLETED	A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
NCT03019991	PHASE1	COMPLETED	Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China
NCT03020134	PHASE1	COMPLETED	Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
NCT03288636	PHASE1	COMPLETED	Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

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