Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Naproxen sodium, Anaprox
Naproxen · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Naproxen Sodium 550 mg Tablets | EXPERIMENTAL | Naproxen Sodium 550 mg Tablets of Dr.Reddy's Laboratories Limited |
| Anaprox DS 550 mg Tablets | ACTIVE_COMPARATOR | Anaprox DS 550 mg Tablets of Roche Pharmaceuticals Inc |
| Anaprox DS 550mg Tablets | ACTIVE_COMPARATOR | Anaprox DS 550mg Tablets of Roche Pharmaceuticals Inc |
| Name | Type | Description |
|---|---|---|
| Naproxen sodium | DRUG | Naproxen Sodium Tablets 550 mg |
Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years. * Non-smokers since at least six months. * Willingness to provide written informed consent to participate in the study. * Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg. * Abse...
Naproxen is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the therapeutic area is classified as other.
Naproxen targets PTGS2 and PTGS1. It acts as an inhibitor of these targets. PTGS2 is also known as cyclooxygenase-2 and PTGS1 as cyclooxygenase-1. This target class places naproxen among inhibitor-class small molecules directed at the prostaglandin synthase enzymes.
Naproxen is developed by Dr. Reddy's Laboratories Ltd, a company whose shares trade under the ticker RDY. Dr. Reddy's Laboratories Ltd is the sponsor associated with the clinical development program for this asset.
Naproxen is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both have completed. The program has no active trials at this time. Naproxen is investigational and has not been approved by the FDA for the studied use.
Naproxen has been studied in two completed Phase 1 trials: NCT01052792, a bioequivalence study of naproxen sodium 550 mg tablets under fed conditions, and NCT01052129, a bioequivalence study of naproxen sodium 550 mg tablets under fasting conditions. Both enrolled 26 healthy volunteers in India, for a total enrollment of 52.
Yes, naproxen sodium is an alternative name for naproxen, and the two names refer to the same drug asset. The clinical trials recorded for this program used naproxen sodium 550 mg tablets, so searches for either name lead to the same development program.