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 medicine developed by Pfizer, Inc. (ticker PFE). It is being studied in a Phase 1 clinical program, and the specific therapeutic indication has not been disclosed. NaxRedy is also written as NaxRedy ™.
NaxRedy is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program studying the asset.
NaxRedy is in Phase 1 clinical development. It is an investigational asset and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
NaxRedy has been studied in one completed Phase 1 trial, NCT05264493, titled Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector. The trial enrolled 13 participants in the United States, used an active-controlled, randomized design, and was conducted in healthy volunteers aged 18 years and older.
Yes. NaxRedy and NaxRedy ™ refer to the same Pfizer asset. NaxRedy ™ is the trademarked styling of the name, so searches for either form point to the same investigational small molecule in Phase 1 development.
NaxRedy is an investigational small molecule in Phase 1 development, and its intended therapeutic indication has not been disclosed. The completed Phase 1 trial, NCT05264493, evaluated bioavailability of a naloxone 5 mg intramuscular autoinjector in healthy volunteers rather than in a patient population.