Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-3242 Tablet
GS-3242 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 2: Part A: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 2 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 3 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. |
| Phase 2: Part B: Group 4 of GS-3242 + LEN | EXPERIMENTAL | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. |
| Phase 3: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks. |
| Phase 3: Group 2 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. |
| Part A: Group 1 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN up to 52 weeks. |
| Part A: Group 2 of GS-3242 + LEN | EXPERIMENTAL | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks. |
| Part A: Group 3 of B/F/TAF | EXPERIMENTAL | Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks. |
| Part B: Group 4 (Conditional) of GS-3242 + LEN | EXPERIMENTAL | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks. |
| Cohort 1: Single Dose of GS-3242 | EXPERIMENTAL | Participants in cohort 1 will receive single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®) (BVY), or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39. Following the completion of Cohort 1, additional cohorts may be opened for enrollment if further data are needed. Doses of GS-3242 will be based on safety and pharmacokinetic (PK) data from ongoing Phase 1a studies. |
| Name | Type | Description |
|---|---|---|
| GS-3242 Tablet | DRUG | Administered orally |
| GS-3242 Injection | DRUG | Administered intramuscularly (IM) |
| Lenacapavir Tablet | DRUG | Administered orally |
| Lenacapavir Injection | DRUG | Administered IM |
| B/F/TAF | DRUG | Administered orally |
| GS-3242 | DRUG | Administered orally |
| BVY | DRUG | Administered orally |
| Standard of Care | DRUG | Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC) |
Key Inclusion Criteria: * HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key Exclusion Criteria: * Prior usage...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
GS-3242 is an investigational small molecule developed by Gilead Sciences, Inc. for the treatment of HIV-1 infection. It is being studied as part of combination regimens in Phase 2 clinical trials. GS-3242 is also referred to as GS-3242 Tablet.
GS-3242 is being developed for the treatment of HIV-1 infection. Phase 2 trials are evaluating it in combination with lenacapavir in people new to HIV-1 treatment and in virologically suppressed people with HIV-1. It is investigational and has not been approved for any use.
GS-3242 targets integrase, a protein essential for HIV-1 replication. By targeting integrase, the drug is designed to interfere with the viral integration process. GS-3242 is a small molecule in the integrase-targeting class being developed by Gilead Sciences.
GS-3242 is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the Phase 2 and Phase 1 clinical trials evaluating GS-3242 in HIV-1 infection.
GS-3242 is in Phase 2 clinical development. Two Phase 2 trials are currently recruiting, and one Phase 1 trial has been completed. GS-3242 is investigational and has not been approved by the FDA for any indication.
GS-3242 is being studied in three trials: NCT07708727, a Phase 2 trial of an injectable regimen with lenacapavir versus Biktarvy in people new to HIV-1 treatment; NCT07645287, a Phase 2 trial with lenacapavir versus Biktarvy in virologically suppressed people; and NCT07001319, a completed Phase 1 substudy.
Yes, GS-3242 Tablet is an alternative name for GS-3242. Both refer to the same investigational small molecule developed by Gilead Sciences for HIV-1 infection. Searches for either name refer to the same asset in Phase 2 development.