Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epinephrine Product · 1 trial · 1 indication
pharmacokinetic analysis
pharmacokinetic analysis
pharmacokinetic analysis
pharmacokinetic analysis
| Arm | Type | Description |
|---|---|---|
| Adults with seasonal allergic rhinitis | EXPERIMENTAL | Single administration of 1.6mg or 3.2 mg Epinephrine powder nasal spray, with or without allergenic challenge, and single IM 0.3 mg Epinephrine without allergenic challenge. |
| Name | Type | Description |
|---|---|---|
| Epinephrine Nasal Product, 1.6 mg | DRUG | Single dose Nasal powder spray without allergen challenge |
| Epinephrine nasal product, 1.6 mg + allergen | DRUG | Single dose Nasal powder spray with allergen challenge |
| Epinephrine Injection 0.3 mg | DRUG | Intramuscular injection |
| Epinephrine Nasal Product, 3.2 mg | DRUG | Twice dose Nasal powder spray without allergen challenge |
| Epinephrine Nasal Product, 3.2 mg + allergen | DRUG | Twice dose Nasal powder spray with allergen challenge |
Inclusion Criteria: The following inclusion criteria will be assessed at screening (within 28 days prior to the first drug administration): 1. Non-smoking, male and female subjects from 18 to 55 years of age. 2. Documented Positive skin allergy test during the last year. 3. History of hay fever, s...
Epinephrine Product is an investigational nasal formulation of epinephrine being developed for the treatment of anaphylaxis. It is a small molecule therapeutic in the immunology area. The product is designed to deliver epinephrine through the nose as an alternative route of administration for this serious allergic emergency.
Epinephrine Product targets the adrenergic receptors ADRA1A, ADRA2A, ADRB1, ADRB2, ADRA2C, and ADRA1D. It acts as an agonist at these receptors. This receptor activity underlies the pharmacologic effects of epinephrine relevant to treating anaphylaxis.
Epinephrine Product is being developed by Nasus Pharma Ltd., which trades under the ticker NSRX. The company is advancing this nasal epinephrine candidate as a potential treatment for anaphylaxis.
Epinephrine Product is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program has completed one trial, and no trials are currently active.
Epinephrine Product has been studied in one completed Phase 1 trial, NCT04696822, titled Bioavailability of Nasal Epinephrine. The trial enrolled 12 healthy adult volunteers in Israel and evaluated the bioavailability of the nasal formulation. It was an uncontrolled study without randomization or double blinding.