Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PN400 · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | PN400 + ASA |
| 2 | PLACEBO_COMPARATOR | Placebo + ASA |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PN400 | DRUG | naproxen 500 mg/esomeprazole 20 mg oral tablet |
| ASA | DRUG | Asprin 81 mg enteric coated tablet |
| Placebo | DRUG | - |
| Naprosyn | DRUG | 500mg Naproxen |
| Naproxen | DRUG | oral tablet |
| Naproxen (Proxen S) | DRUG | Oral |
| Naproxen (Naprosyn E) | DRUG | Oral |
Inclusion Criteria: * Stable without clinically significant disease Exclusion Criteria: * Use of NSAID within 2 weeks * Type 1 or 2 DM * GI disorder
PN400 is an investigational small molecule being studied in healthy volunteers for platelet inhibition. It is a combination product containing naproxen and esomeprazole, evaluated in Phase 1 clinical trials for its bioavailability and effects on serum thromboxane B2 levels.
PN400 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company has sponsored Phase 1 clinical trials of PN400 in healthy volunteers.
PN400 is in Phase 1 clinical development. All four clinical trials for PN400 have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
PN400 has been studied in four completed Phase 1 trials. NCT00761501 and NCT00907400 evaluated bioavailability of naproxen as PN400 compared to other naproxen formulations. NCT00992381 compared a combination of esomeprazole and naprosyn versus naprosyn alone. NCT01094483 assessed inhibition of serum thromboxane B2 levels with PN400 and low dose aspirin.
PN400 combines naproxen, a nonsteroidal anti-inflammatory drug, with esomeprazole, a proton pump inhibitor. Naproxen works by inhibiting cyclooxygenase enzymes to reduce prostaglandin synthesis, while esomeprazole reduces stomach acid production to protect the gastrointestinal tract.