Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX-787 · 1 trial · 1 indication
Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
| Arm | Type | Description |
|---|---|---|
| VX-787 Placebo BID + Oseltamivir Placebo BID | PLACEBO_COMPARATOR | Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 300 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg (2\*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir 75 mg BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg tablets (2\*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| Name | Type | Description |
|---|---|---|
| VX-787 300 mg | DRUG | A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days. |
| VX-787 600 mg | DRUG | A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days. |
| Oseltamivir 75 mg | DRUG | A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days. |
| Placebo | DRUG | Subjects will receive matching placebo of Oseltamivir |
Inclusion Criteria: Part A 1. Willing and able to comply with the NP swab procedure 2. Subject will sign and date an informed consent form (ICF) 3. Presenting to the clinic with symptoms suggestive of a diagnosis of acute influenza. Symptoms include oral temperature ≥38°C (100.4°F) within the prior...
Top 8 of 11 competitors
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| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
VX-787 is an investigational small molecule developed for the treatment of influenza A, specifically acute uncomplicated seasonal influenza A in adults. It is being studied in a Phase 2 clinical program and is not yet approved for any indication.
VX-787 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson holds the development rights for this compound.
VX-787 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
VX-787 has been evaluated in one completed Phase 2 trial, NCT02342249, titled "Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects." This randomized, double-blind, placebo-controlled trial enrolled 292 adults across the United States, Belgium, Bulgaria, Canada, Estonia, Germany, Latvia, Puerto Rico, and South Africa.