Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dolutegravir Dispersible Tablet
Dolutegravir Dispersible · 1 trial · 1 indication
Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Subject receiving Dolutegravir 10 mg | EXPERIMENTAL | Subject will receive a prototype equivalent to DTG 10 mg liquid formulation in period 1, a prototype equivalent to DTG 10 mg liquid formulation in period 2, a DTG 10 mg dispersible tablet in Period 3, each period will be separated by washout period of \>= 7 days, if required a prototype equivalent to DTG 10 mg liquid formulation in period 4, a prototype equivalent to DTG 10 mg liquid formulation in period 5, and a prototype equivalent to DTG 10 mg liquid formulation in period 6 will be evaluated. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir dispersible tablet | DRUG | DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen. |
| Dolutegravir oral suspension | DRUG | DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen. |
| Dolutegravir oral solution | DRUG | DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen. |
Inclusion Criteria: * Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation. * Body weight \>= 50 ...
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 Dispersible is a dispersible tablet formulation of dolutegravir, a small molecule being developed by GSK plc (ticker: GSK) for the treatment of HIV Infections. It is designed as an orally dispersible dosage form, which allows the tablet to be mixed with liquid before administration.
Dolutegravir Dispersible is being developed for the treatment of HIV Infections. It is a dispersible tablet formulation intended to provide an orally dispersible option of dolutegravir, which may be relevant for patients who have difficulty swallowing standard tablets.
Dolutegravir Dispersible is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor responsible for the clinical development of this dispersible tablet formulation of dolutegravir.
Dolutegravir Dispersible is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. The Phase 1 program includes one completed trial evaluating the pediatric liquid formulation.
Dolutegravir Dispersible has been evaluated in one completed Phase 1 trial, NCT03921723, titled Dolutegravir Pediatric Liquid Formulation Study. The trial enrolled 22 participants in the United Kingdom, included healthy volunteers, and was an uncontrolled study without randomization or double-blinding.
Yes, Dolutegravir Dispersible is also known as Dolutegravir Dispersible Tablet and Dolutegravir dispersible tablet. These names refer to the same dispersible tablet formulation of dolutegravir being developed by GSK plc for HIV Infections.