Sunlenca(lenacapavir sodium)
Sunlenca (lenacapavir sodium) is a small molecule pharmaceutical. Lenacapavir sodium was first approved as Sunlenca on 2022-08-17. It is used to treat hiv-1 in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Sunlenca, Yeztugo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lenacapavir sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUNLENCA | Gilead Sciences | N-215973 RX | 2022-12-22 | 1 products, RLD, RS |
| YEZTUGO | Gilead Sciences | N-220018 RX | 2025-06-18 | 1 products, RLD, RS |
| SUNLENCA | Gilead Sciences | N-215974 RX | 2022-12-22 | 1 products, RLD, RS |
| YEZTUGO | Gilead Sciences | N-220020 RX | 2025-06-18 | 1 products, RLD, RS |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LENACAPAVIR SODIUM, SUNLENCA, GILEAD SCIENCES INC | |||
| 2027-12-22 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 11 | 8 | 1 | 2 | 22 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | 1 | — | — | 3 |
| Communicable diseases | D003141 | — | — | 1 | 1 | 1 | — | — | 3 |
| Hepatitis c | D006526 | — | B19.2 | — | — | 1 | — | — | 1 |
| Hepatitis b | D006509 | — | — | — | — | 1 | — | — | 1 |
| Hepatitis | D006505 | — | K75.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lenacapavir sodium |
| INN | lenacapavir |
| Description | Lenacapavir, sold under the brand name Sunlenca, is an antiretroviral medication used to treat HIV/AIDS. It is taken by mouth or by subcutaneous injection.
|
| Classification | Small molecule |
| Drug class | antivirals: viral capsid inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(C#Cc1ccc(-c2ccc(Cl)c3c([N-]S(C)(=O)=O)nn(CC(F)(F)F)c23)c([C@H](Cc2cc(F)cc(F)c2)NC(=O)Cn2nc(C(F)(F)F)c3c2C(F)(F)[C@@H]2C[C@H]32)n1)S(C)(=O)=O.[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 2283356-12-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4802249 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15673 |
| UNII ID | A9A0O6FB4H (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Yeztugo
Adverse Events
Top Adverse Reactions
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394 adverse events reported
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