ombitasvir
Trade name: Viekira Pak
Small moleculeapprovedFast Track FDABreakthrough Therapy FDA
Approved
Dec 19, 2014
Ombitasvir (ABT-267) is an antiviral drug for the treatment of hepatitis C virus (HCV) infection. Ombitasvir is a potent inhibitor of the hepatitis C virus protein NS5A, has favorable pharmacokinetic characteristics and is active in the picomolar range against genotype 1 - 6. In 2015, it was approved by FDA for use in combination with paritaprevir, ritonavir and dasabuvir in the product Viekira Pak for the treatment of HCV genotype 1. — NCATS
Clinical trial activity
70 trials · 30 clinical orgs · 1 marketing orgs
Phase 1
6
Phase 2
51
Phase 3
35
Phase 4
13
Earliest trial started Sep 1, 2011 (NCT01458535)
Timeline
Indications
Approved for
Studied for
- Dengue · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Fibrosis · Phase 3
- Genotype · Phase 3
- Healthy Volunteers · Phase 1
- Hepacivirus · Phase 4
- Hepatitis B · Phase 2/Phase 3
- Hepatitis Viruses · Phase 4
- HIV · Phase 3
- HIV Infections · Phase 2
- Kidney Diseases · Phase 3
- Kidney Failure, Chronic · Phase 4
- Liver Cirrhosis · Phase 3
- Pharmacology · Phase 1
- Renal Insufficiency, Chronic · Phase 4
Mechanism of action
- Nonstructural protein 5AINHIBITOR
NS5A inhibitor
Combination products
technivie
with ritonavir, paritaprevir
Also known as ombitasvir, paritaprevir, ritonavir
viekira pak (copackaged)
with ritonavir, paritaprevir, dasabuvir
Also known as dasabuvir, ombitasvir, paritaprevir, and ritonavir, ombitasvir and paritaprevir and ritonavir and dasabuvir, viekira xr
Approval history
- approvedPriority reviewFast trackBreakthroughDec 19, 2014
Chemistry & pharmacology
Loading structure…
SMILES
COC(=O)N[C@@H](C(C)C)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(NC(=O)[C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)C(C)C)C=C5- Mol. weight
- 894.1091 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaOmbitasvir ↗
- NCATS2302768XJ8 ↗
- ChEMBLCHEMBL3127326 ↗
Also known as
- abt-267
- abt-267
- abt-267
- abt-267
- abt-267
- abt-333
- dimethyl ([(2s,5s)-1-(4-tert-butylphenyl)pyrrolidine-2,5-diyl]bis{(4,1-phenylene)carbamoyl(2s)pyrrolidine-2,1-diyl[(2s)-3-methyl-1-oxobutane-1,2-diyl]})biscarbamate
- dimethyl ([(2s,5s)-1-(4-tert-butylphenyl)pyrrolidine-2,5-diyl]bis{(4,1-phenylene)carbamoyl(2s)pyrrolidine-2,1-diyl[(2s)-3-methyl-1-oxobutane-1,2-diyl]})biscarbamate
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir
- ombitasvir heminonahydrate
- ombitasvir hydrate
- ombitasvir / paritaprevir / ritonavir
- ombitsavir
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06799741 | Phase 2 | Jan 7, 2025 | AbViro LLC |
| NCT04273217 | Phase 1 | Feb 4, 2020 | AbViro LLC, National Institute of Allergy and Infectious Diseases (NIAID), PPD |
| NCT03499639 | Phase 4 | May 1, 2018 | Assiut University, Sohag University, South Valley University |
| NCT03549832 | N/A | Jan 1, 2018 | Assiut University, Sohag University, South Valley University |
| NCT03341988 | Phase 1 | Nov 22, 2017 | Assiut University |
| NCT03296930 | Phase 4 | Oct 1, 2017 | Assiut University |
| NCT02874066 | Phase 4 | Mar 13, 2017 | AbbVie, National Taiwan University |
| NCT03050905 | Phase 4 | Mar 1, 2017 | AbbVie, Emek Medical Center |
| NCT04391985 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2017 | Beni Suef University |
| NCT02946034 | Phase 4 | Feb 1, 2017 | AbbVie, Harvard University |
| NCT04378608 | Phase 1/Phase 2 (Phase 2) | Jan 5, 2017 | Beni Suef University |
| NCT02950870 | Phase 4 | Dec 1, 2016 | University of Modena and Reggio Emilia |
| NCT03067883 | Phase 2 | Nov 9, 2016 | Ain Shams University |
| NCT02806362 | Phase 3 | Sep 1, 2016 | AbbVie |
| NCT02786537 | Phase 4 | Jun 1, 2016 | AbbVie, Cancer Research Network, Merck, University of Florida |
| NCT02634008 | Phase 3 | Jun 1, 2016 | AbbVie, University of New South Wales |
| NCT02498015 | Phase 4 | Jun 1, 2016 | University of New South Wales |
| NCT03003338 | Phase 4 | May 1, 2016 | AbbVie, Gottfried Wilhelm Leibniz Universität Hannover, Hannover Clinical Trial Center GmbH |
| NCT03710252 | Phase 4 | Mar 31, 2016 | AbbVie, American Research Corporation (ARC) |
| NCT02707952 | Phase 3 | Feb 1, 2016 | AbbVie |
Showing 20 of 70 trials
Page 1 / 4
Organizations
Research & Development (30)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AbbVie | For profit | 56 | 47 | 4 | 2011 |
| Assiut University | Academic/Hospital | 4 | 4 | 3 | 2017 |
| AbViro LLC | For profit | 2 | 2 | 2 | 2020 |
| Beni Suef University | Academic/Hospital | 2 | 2 | 1 | 2017 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 1 | 2 | 2015 |
| Sohag University | Academic/Hospital | 2 | 0 | 2 | 2018 |
| South Valley University | Academic/Hospital | 2 | 0 | 2 | 2018 |
| University of New South Wales | Academic/Hospital | 2 | 2 | 2 | 2016 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| American Research Corporation (ARC) | For profit | 1 | 1 | 1 | 2016 |
| Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Dalhousie University | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Emek Medical Center | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Government of Canada | Government | 1 | 0 | 1 | 2015 |
| Government of Nova Scotia | Government | 1 | 1 | 1 | 2015 |
| Hannover Clinical Trial Center GmbH | For profit | 1 | 0 | 1 | 2016 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Humanity & Health Research Centre | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2015 |
30 organizations
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