Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dolutegravir film-coated tablets
Dolutegravir film-coated · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dolutegravir (DTG) | EXPERIMENTAL | Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands. |
| Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | EXPERIMENTAL | Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir film-coated tablets | DRUG | Dolutegravir film-coated tablets will be provided as 50 mg tablets. |
| Dolutegravir film-coated dispersible tablets | DRUG | Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band. |
| ABC/DTG/3TC immediate release tablets | DRUG | ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC. |
| ABC/DTG/3TC film-coated dispersible tablets | DRUG | ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC. |
Inclusion Criteria: * Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product: 1. P1093 parent study through at least Week 180; 2. P2019 parent study through at least Week 48. * Participan...
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 |
Dolutegravir film-coated is used to treat HIV Infections. It is a small molecule antiviral medicine developed by GSK plc. The film-coated tablet form is studied in HIV-1 participants, including children and adolescents completing prior pediatric HIV studies.
Dolutegravir film-coated is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with this film-coated tablet formulation of dolutegravir in the HIV Infections therapeutic area.
Dolutegravir film-coated is in Phase 3 clinical development for HIV Infections. It is an investigational asset in this program and is not described as approved. The Phase 3 study supporting this formulation has been completed.
Dolutegravir film-coated has been studied in one Phase 3 trial, NCT03016533, titled Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019. That trial is completed, enrolled 100 participants, used a controlled design, and ran in the United States, Botswana, Brazil, South Africa, Tanzania, Thailand, and Zimbabwe.
Yes, dolutegravir film-coated is also known as dolutegravir film-coated tablets. Both names refer to the same film-coated tablet formulation of dolutegravir developed by GSK plc for HIV Infections.