Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NaxRedy · 1 trial · 1 indication
Comparison of bioavailability
Comparison of bioavailability
| Arm | Type | Description |
|---|---|---|
| naloxone 5 mg IM autoinjector | EXPERIMENTAL | participants will receive in random order, a single naloxone 5 mg IM autoinjector injection into the lateral thigh |
| naloxone 2 mg IM | ACTIVE_COMPARATOR | participants will receive in random order, a single naloxone 2 mg IM injection into the gluteus muscle |
| naloxone 2mg bolus IV | ACTIVE_COMPARATOR | participants will receive in random order, a single naloxone 2 mg bolus IV injection |
| Name | Type | Description |
|---|---|---|
| NaxRedy ™ | DRUG | 5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh |
| Naloxone Hydrochloride Injection, USP | DRUG | 2 mg IM (2mg/2 mL) injection into gluteal muscle |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1. Healthy male and/or female participants of non-childbearing potential, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Refe...
NaxRedy is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioavailability study evaluating its use in healthy adult participants. The drug is not yet approved and remains under clinical investigation.
NaxRedy is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational small molecule drug candidate.
NaxRedy is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation in healthy volunteers.
NaxRedy has one completed Phase 1 clinical trial, identified as NCT05264493, titled "Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector." This study enrolled 13 healthy volunteers in the United States and was an active-controlled, randomized trial.
NaxRedy is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 bioavailability study has been completed, but the drug has not received regulatory approval and remains under clinical investigation.