Epclusa(velpatasvir)
Epclusa, Vosevi (velpatasvir) is a small molecule pharmaceutical. Velpatasvir was first approved as Epclusa on 2016-06-28. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Epclusa, Vosevi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sofosbuvir
+
Velpatasvir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EPCLUSA | Gilead Sciences | N-208341 RX | 2016-06-28 | 2 products, RLD, RS |
| EPCLUSA | Gilead Sciences | N-214187 RX | 2021-06-10 | 2 products, RLD, RS |
Sofosbuvir
+
Velpatasvir
+
Voxilaprevir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOSEVI | Gilead Sciences | N-209195 RX | 2017-07-18 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| epclusa | New Drug Application | 2024-06-05 |
| epclusa access | Export only | 2020-12-18 |
| sofosbuvir and velpatasvir | NDA authorized generic | 2022-05-04 |
| vosevi | New Drug Application | 2024-03-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatitis c | — | D006526 | B19.2 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SOFOSBUVIR / VELPATASVIR, EPCLUSA, GILEAD SCIENCES INC | |||
| 2028-12-10 | PED | ||
| 2028-06-10 | ODE-376 | ||
| 2027-09-19 | PED | ||
| 2027-03-19 | ODE-293 | ||
| 2025-04-27 | M-277 | ||
| 2024-01-14 | PED | ||
| 2023-07-14 | M-264 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc | |||
| 10912814 | 2037-06-01 | DP | |
| 11338007 | 2037-06-01 | DP | U-2039, U-2040 |
| 9296782 | 2034-07-17 | DS, DP | |
| 9868745 | 2032-11-16 | DS, DP | |
| 8957046 | 2028-03-21 | U-2039, U-2040 | |
| Sofosbuvir / Velpatasvir, Epclusa, Gilead Sciences Inc | |||
| 9757406 | 2034-01-30 | DP | |
| 10086011 | 2034-01-30 | U-1470 | |
| 11116783 | 2034-01-30 | DP | U-1470, U-2039, U-2040 |
| 11707479 | 2034-01-30 | DP | U-1470 |
| 8575135 | 2032-11-16 | DS, DP | U-1470, U-2039, U-2040 |
| 8921341 | 2032-11-16 | DS, DP | U-1470, U-2039, U-2040 |
| 8940718 | 2032-11-16 | DS, DP | U-1470, U-2039, U-2040 |
| 8618076 | 2030-12-11 | DS, DP | U-1470, U-2039, U-2040 |
| 9284342 | 2030-09-13 | DS, DP | U-1470, U-2039, U-2040 |
| 7964580 | 2029-03-26 | DS, DP | U-1470, U-2039, U-2040 |
| 8633309 | 2029-03-26 | DS, DP | U-1470, U-2039, U-2040 |
| 8889159 | 2029-03-26 | DP | U-1470, U-2039, U-2040 |
| 8334270 | 2028-03-21 | DS, DP | U-1470, U-2039, U-2040 |
| 8580765 | 2028-03-21 | DS, DP | U-1470, U-2039, U-2040 |
| 8735372 | 2028-03-21 | U-1470, U-2039, U-2040 | |
| 9085573 | 2028-03-21 | DS, DP | U-1470, U-2039, U-2040 |
HCPCS
No data
Clinical
Clinical Trials
123 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | — | B19.2 | 13 | 29 | 22 | 30 | 30 | 121 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 10 | 18 | 17 | 20 | 23 | 85 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 8 | 12 | 9 | 15 | 21 | 63 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 4 | 7 | 3 | 13 | 16 | 43 |
| Hepatitis b | D006509 | — | — | 1 | 10 | 16 | 2 | 4 | 33 |
| Infections | D007239 | EFO_0000544 | — | 1 | 8 | 15 | 2 | 4 | 30 |
| Communicable diseases | D003141 | — | — | 1 | 8 | 12 | 2 | 3 | 26 |
| Virus diseases | D014777 | — | B34 | 1 | 3 | 5 | 2 | 1 | 11 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 3 | — | 2 | 3 | 9 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | 4 | 2 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 1 | 2 | 1 | — | — | 3 |
| Cryoglobulinemia | D003449 | EFO_0005846 | D89.1 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 2 | — | — | — | 2 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 1 | — | — | — | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 1 | — | — | — | 1 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recreational drug use | D000084783 | — | — | — | — | — | — | 2 | 2 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
| Rna virus infections | D012327 | — | — | — | — | — | — | 1 | 1 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | — | — | — | 1 | 1 |
| Viral hepatitis human | D006525 | EFO_0004196 | — | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | — | — | 1 | 1 |
| Intravenous substance abuse | D015819 | — | — | — | — | — | — | 1 | 1 |
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Velpatasvir |
| INN | velpatasvir |
| Description | Velpatasvir is a complex organic heteropentacyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with sofosbuvir (under the brand name Epclusa) for treatment of patients with chronic hepatitis C of all six major genotypes. It has a role as an antiviral drug and a hepatitis C virus nonstructural protein 5A inhibitor. It is an organic heteropentacyclic compound, a N-acylpyrrolidine, a L-valine derivative, a carbamate ester, a member of imidazoles, a ring assembly and an ether. |
| Classification | Small molecule |
| Drug class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1 |
Identifiers
| PDB | — |
| CAS-ID | 1377049-84-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545062 |
| ChEBI ID | — |
| PubChem CID | 67683363 |
| DrugBank | DB11613 |
| UNII ID | KCU0C7RS7Z (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Epclusa – Gilead Sciences
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Vosevi – Gilead Sciences
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,900 documents
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Safety
Black-box Warning
Black-box warning for: Epclusa, Epclusa access, Sofosbuvir and velpatasvir, Vosevi
Adverse Events
Top Adverse Reactions
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18,297 adverse events reported
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