Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-323 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| EDP-323, midazolam, caffeine and rosuvastatin | EXPERIMENTAL | Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days |
| EDP-323 and itraconazole interaction (Part 1) | EXPERIMENTAL | Subjects will receive EDP-323 and itraconazole on respective dosing days |
| EDP-323 and carbamazepine interaction (Part 2) | EXPERIMENTAL | Subjects will receive EDP-323 and carbamazepine on respective dosing days |
| EDP-323 and quinidine interaction (Part 3) | EXPERIMENTAL | Subjects will receive EDP-323 and quinidine on respective dosing days |
| EDP-323 and fluconazole interaction (Part 4) | EXPERIMENTAL | Subjects will receive EDP-323 and fluconazole on respective dosing days |
| EDP-323 SAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration |
| EDP-323 MAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days |
| EDP-323 SAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-323 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-323 | DRUG | Subjects will receive EDP-323 once daily on Days 5-15 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Days 1 and 12 |
| Caffeine | DRUG | Subjects will receive caffeine once daily on Days 1 and 12 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD Days 5-18 |
| carbamazepine | DRUG | Subjects will receive carbamazepine on Days 5 - 27 |
| Quinidine | DRUG | Subjects will receive quinidine on Days 5-12 |
| fluconazole | DRUG | Subjects will receive fluconazole on Days 5-18 |
| Placebo | DRUG | Placebo to match EDP-323, oral administration |
Inclusion Criteria: * An informed consent document signed and dated by the subject * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive * Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2 * Female subjects of childbearing pot...
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 |
EDP-323 is an investigational small molecule antiviral being developed by Enanta Pharmaceuticals for the treatment of respiratory syncytial virus, or RSV, infection. It is designed to target the RSV L-protein and is currently in Phase 1 clinical development.
EDP-323 targets the RSV L-protein, a viral protein class target. By acting on the L-protein, the drug is intended to interfere with RSV viral replication. This mechanism underlies its development as an antiviral candidate for RSV infection.
EDP-323 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. Enanta is the sponsor of the clinical program evaluating the drug in RSV infection.
EDP-323 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All three of its registered Phase 1 trials have been completed, and no trials are currently active.
EDP-323 has been studied in three completed Phase 1 trials: NCT05587478, a healthy subject study with 82 participants; NCT06847464, a drug-drug interaction study with 48 participants; and NCT06917508, a drug-drug interaction study with midazolam, caffeine, and rosuvastatin in 24 participants. All enrolled healthy volunteers in the United States.