Harvoni(ledipasvir)
Harvoni (ledipasvir) is a small molecule pharmaceutical. Ledipasvir was first approved as Harvoni on 2014-10-10. 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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Trade Name
FDA
EMA
Combinations
Harvoni
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| harvoni | New Drug Application | 2021-03-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| hepatitis c | — | D006526 | B19.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEDIPASVIR / SOFOSBUVIR, HARVONI, GILEAD SCIENCES INC | |||
| 2026-08-28 | ODE*, ODE-262, ODE-263, ODE-264 | ||
| 2024-10-07 | PED | ||
| 2024-04-07 | ODE*, ODE-136 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ledipasvir / Sofosbuvir, Harvoni, Gilead Sciences Inc | |||
| 10039779 | 2034-01-30 | DS, DP | U-1470, U-2369, U-2370 |
| 9393256 | 2032-09-14 | U-1470 | |
| 10456414 | 2032-09-14 | DP | |
| 8618076 | 2030-12-11 | DS, DP | U-1470 |
| 9284342 | 2030-09-13 | DS, DP | U-1470 |
| 8088368 | 2030-05-12 | DS, DP | |
| 8273341 | 2030-05-12 | U-1470 | |
| 8822430 | 2030-05-12 | DS, DP | U-1470 |
| 8841278 | 2030-05-12 | DP | U-1470 |
| 9511056 | 2030-05-12 | DP | U-1470 |
| 7964580 | 2029-03-26 | DS, DP | U-1470 |
| 8633309 | 2029-03-26 | DS, DP | U-1470 |
| 8889159 | 2029-03-26 | DP | U-1470 |
| 8334270 | 2028-03-21 | DS, DP | U-1470 |
| 8580765 | 2028-03-21 | DS, DP | U-1470 |
| 8735372 | 2028-03-21 | U-1470 | |
| 9085573 | 2028-03-21 | DS, DP | U-1470 |
HCPCS
No data
Clinical
Clinical Trials
68 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 | 2 | 7 | 5 | 9 | 5 | 27 | |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 9 | 3 | 4 | 2 | 19 |
| Hiv | D006678 | O98.7 | — | 2 | 1 | 1 | — | 4 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | 1 | 1 | 3 |
| Covid-19 | D000086382 | U07.1 | — | — | 1 | 1 | — | 2 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | 1 | 1 | 2 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | 1 | — | 2 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | — | 1 | 1 | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | 1 | — | — | 4 |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 1 | 2 | — | 1 | 3 |
| Hepatitis b | D006509 | — | 1 | 1 | — | 1 | 3 | ||
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 1 | 1 | — | — | 2 |
| Cryoglobulinemia | D003449 | EFO_0005846 | D89.1 | — | 1 | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEDIPASVIR |
| INN | ledipasvir |
| Description | Ledipasvir is a benzimidazole derivative that is used in combination with sofosbuvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. It has a role as an antiviral drug and a hepatitis C protease inhibitor. It is a carbamate ester, a L-valine derivative, a bridged compound, a carboxamide, a benzimidazole, a member of fluorenes, an organofluorine compound, a member of imidazoles, a N-acylpyrrolidine and an azaspiro compound. |
| Classification | Small molecule |
| Drug class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C |
Identifiers
| PDB | — |
| CAS-ID | 1256388-51-8 |
| RxCUI | 1591922 |
| ChEMBL ID | CHEMBL2374220 |
| ChEBI ID | 85089 |
| PubChem CID | 67505836 |
| DrugBank | DB09027 |
| UNII ID | 013TE6E4WV (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
Harvoni - Gilead Sciences
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Trends
PubMed Central
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Additional graphs summarizing 4,432 documents
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Safety
Black-box Warning
Black-box warning for: Harvoni
Adverse Events
Top Adverse Reactions
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1,182 adverse events reported
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