Overview
HIV/AIDS remains an area of concern despite the introduction of numerous successful therapies, mainly due to the emergence of multidrug resistance and patient difficulty in adhering to treatment regimens. Lenacapavir is a first-in-class capsid inhibitor that demonstrates picomolar HIV-1 inhibition as a monotherapy in vitro, little to no cross-resistance with existing antiretroviral agents, and extended pharmacokinetics with subcutaneous dosing. Lenacapavir was first globally approved on August 22, 2022 by the European Commission to treat adults with multi-drug resistant HIV infection. On December 22, 2022, it was also approved by the FDA.
Indication
Lenacapavir, in combination with other antiretroviral(s), is indicated for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults who are experiencing a failure of their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Associated Conditions
- Multidrug resistant HIV-1 infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/02 | Not Applicable | Recruiting | |||
2025/02/11 | Phase 1 | Not yet recruiting | |||
2025/01/29 | N/A | Recruiting | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | ||
2024/12/27 | Phase 2 | Recruiting | |||
2024/08/01 | Phase 2 | Recruiting | |||
2024/07/22 | Phase 2 | Active, not recruiting | |||
2024/03/27 | Phase 3 | Active, not recruiting | |||
2023/10/26 | Phase 2 | Active, not recruiting | |||
2023/10/26 | Phase 2 | Active, not recruiting | |||
2023/02/15 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gilead Sciences | 61958-3001 | ORAL | 300 mg in 1 1 | 9/8/2025 | |
| Gilead Sciences, Inc. | 61958-3001 | ORAL | 300 mg in 1 1 | 9/8/2025 | |
| Gilead Sciences, Inc. | 61958-3401 | ORAL | 300 mg in 1 1 | 9/8/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/17/2022 | ||
Authorised | 8/17/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Sunlenca film-coated tablet 300mg | SIN17188P | TABLET, FILM COATED | 300mg | 2/27/2025 | |
| Sunlenca solution for injection 463.5mg/1.5ml | SIN17189P | INJECTION, SOLUTION | 463.5mg/1.5ml | 2/27/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SUNLENCA lenacapavir (as sodium) 300 mg film coated tablet blister pack | 392350 | Medicine | A | 3/27/2023 | |
| SUNLENCA lenacapavir (as sodium) 463.5 mg/1.5 mL solution for injection vial | 386895 | Medicine | A | 3/27/2023 | |
| SUNLENCA lenacapavir (as sodium) 300 mg film coated tablet bottle | 468505 | Medicine | A | 7/11/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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