Ombitasvir
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Also known as ABT-267Ombitasvir component of technivieOmbitasvir component of viekirax
Summary
Ombitasvir (CHEMBL3127326) is an approved small-molecule antiviral drug; indicated across 3 conditions including chronic hepatitis c virus infection and hepatitis c virus infection.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- Indications: 3 conditions
- Clinical trials: 53
- Chemistry: 894.1 Da · C50H67N7O8
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3127326 |
| Name | Ombitasvir |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | no |
| PubChem CID | 54767916 |
| ChEBI | CHEBI:85183 |
| Molecular formula | C50H67N7O8 |
| Molecular weight | 894.1 |
| InChIKey | PIDFDZJZLOTZTM-KHVQSSSXSA-N |
SMILES: CC(C)[C@@H](C(=O)N1CCC[C@H]1C(=O)NC2=CC=C(C=C2)[C@@H]3CC[C@H](N3C4=CC=C(C=C4)C(C)(C)C)C5=CC=C(C=C5)NC(=O)[C@@H]6CCCN6C(=O)[C@H](C(C)C)NC(=O)OC)NC(=O)OC
IUPAC name: methyl N-[(2S)-1-[(2S)-2-[[4-[(2S,5S)-1-(4-tert-butylphenyl)-5-[4-[[(2S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidine-2-carbonyl]amino]phenyl]pyrrolidin-2-yl]phenyl]carbamoyl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
ChEBI definition: A dipeptide derivative which is used which is in combination with dasabuvir sodium hydrate, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.
Pharmacological roles (ChEBI): antiviral drug, hepatitis C virus nonstructural protein 5A inhibitor.
Also known as: ABT-267, Ombitasvir, Ombitasvir component of technivie, Ombitasvir component of viekirax, OMBITASVIR
Patent coverage: 430 distinct patent families (1,044 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Genome polyprotein.
Bioactivity
ChEMBL activities: 4 potent at pChembl ≥ 5 of 4 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):
| Target | pChembl | Type | Value | Unit | Activity ID |
|---|---|---|---|---|---|
| Q9WMX2 | 10.92 | EC50 | 0.01 | nM | CHEMBL_ACT_18475935 |
| Q9WMX2 | 10.72 | EC50 | 0.02 | nM | CHEMBL_ACT_18476076 |
| Q9WMX2 | 10.25 | EC50 | 0.06 | nM | CHEMBL_ACT_18475959 |
| Q9WMX2 | 9.44 | EC50 | 0.37 | nM | CHEMBL_ACT_18476135 |
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
3 indications (2 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 |
|---|---|---|---|
| chronic hepatitis C virus infection | 4 | MONDO:0005354 | EFO:0004220 |
| hepatitis C virus infection | 4 | MONDO:0005231 | EFO:0003047 |
| hepatitis B virus infection | 2 | MONDO:0005344 | EFO:0004197 |
Clinical trials
Total trials: 53.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 24 |
| PHASE2 | 10 |
| Not specified | 10 |
| PHASE4 | 3 |
| PHASE2/PHASE3 | 3 |
| PHASE1 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT02460133 | PHASE4 | ACTIVE_NOT_RECRUITING | Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment |
| NCT03296930 | PHASE4 | UNKNOWN | Effect Of DAAs For Treatment Of HCV On Normal Kidney |
| NCT03499639 | PHASE4 | COMPLETED | Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV and End-stage Kidney Disease |
| NCT01715415 | PHASE3 | COMPLETED | A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults |
| NCT01716585 | PHASE3 | COMPLETED | A Study to Evaluate Chronic Hepatitis C Infection |
| NCT01773070 | PHASE3 | COMPLETED | A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study |
| NCT01939197 | PHASE2/PHASE3 | COMPLETED | A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection |
| NCT02023099 | PHASE3 | COMPLETED | Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection |
| NCT02023112 | PHASE3 | COMPLETED | Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection |
| NCT02167945 | PHASE3 | COMPLETED | A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection |
| NCT02207088 | PHASE3 | COMPLETED | Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease |
| NCT02216422 | PHASE3 | COMPLETED | A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection |
| NCT02219477 | PHASE3 | COMPLETED | A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis |
| NCT02219490 | PHASE3 | COMPLETED | A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection |
| NCT02219503 | PHASE3 | COMPLETED | A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis |
| NCT02265237 | PHASE3 | COMPLETED | A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) |
| NCT02399345 | PHASE3 | COMPLETED | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults |
| NCT02442271 | PHASE3 | COMPLETED | A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil |
| NCT02442284 | PHASE3 | COMPLETED | A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection |
| NCT02476617 | PHASE3 | COMPLETED | Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults |
| NCT02486406 | PHASE2/PHASE3 | COMPLETED | A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects |
| NCT02487199 | PHASE3 | COMPLETED | Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease |
| NCT02504099 | PHASE3 | TERMINATED | A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma |
| NCT02517515 | PHASE3 | COMPLETED | ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection |
| NCT02517528 | PHASE3 | COMPLETED | ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis |
| NCT02555943 | PHASE2/PHASE3 | COMPLETED | DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) |
| NCT02582632 | PHASE3 | COMPLETED | A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults |
| NCT02609659 | PHASE3 | COMPLETED | Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection |
| NCT02634008 | PHASE3 | COMPLETED | Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P |
| NCT02806362 | PHASE3 | WITHDRAWN | Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD) |
| NCT01314261 | PHASE2 | COMPLETED | Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects |
| NCT01458535 | PHASE2 | COMPLETED | A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) |
| NCT01464827 | PHASE2 | COMPLETED | ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients |
| NCT01563536 | PHASE2 | COMPLETED | Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects |
| NCT01609933 | PHASE2 | COMPLETED | A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study |
| NCT01685203 | PHASE2 | COMPLETED | A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection |
| NCT01782495 | PHASE2 | COMPLETED | A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients |
| NCT01911845 | PHASE2 | COMPLETED | An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine |
| NCT02356562 | PHASE2 | COMPLETED | A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection |
| NCT02493855 | PHASE2 | COMPLETED | Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).