Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nabumetone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Nabumetone | EXPERIMENTAL | Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited |
| Relafen | ACTIVE_COMPARATOR | Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. |
| Name | Type | Description |
|---|---|---|
| Nabumetone | DRUG | Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited |
| Relafen | DRUG | Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. |
Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects who will provide written informed consent * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Having a Body Mass I...
Nabumetone is a small molecule drug developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been publicly disclosed, and its therapeutic area is classified as other.
Nabumetone targets PTGS2, also known as cyclooxygenase-2. It acts as an inhibitor of this enzyme. PTGS2 is involved in the inflammatory response, and inhibiting it is the basis for the drug's mechanism of action as a small molecule therapeutic.
Nabumetone is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is conducting clinical development of the drug, including bioequivalence studies of its 750 mg tablets.
Nabumetone is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 trials have been completed, with no active trials currently ongoing. The trials enrolled a total of 74 participants.
Nabumetone has been evaluated in two completed Phase 1 bioequivalence trials. NCT01164826 studied 750 mg tablets under fed conditions in 30 healthy volunteers, and NCT01164813 studied the same tablets under fasting conditions in 44 healthy volunteers. Both trials were conducted in India.
Yes, the Nabumetone Phase 1 trials were randomized and used an active control design. They were not double-blind. Both studies enrolled healthy adult volunteers aged 18 years and older, and both have been completed.