Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMXIN002 · 1 trial · 2 indications
Plasma level of Epinephrine
Pharmacodynamic response
Pharmacodynamic response
Pharmacodynamic response
| Arm | Type | Description |
|---|---|---|
| 6 Healthy volunteers, sequence ABC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: A B C |
| 6 Healthy volunteers, sequence BAC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: B A C |
| Name | Type | Description |
|---|---|---|
| A: Epinephrine injection | DRUG | Autoinjector for intramuscular, single-use, 0.3mg |
| B: FMXIN002 3.6mg | DRUG | Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril |
| C: FMXIN002 4.0mg | DRUG | Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril |
Inclusion Criteria: * 1\) Non-smoking, male and female subjects from 18 to 55 years of age. 2) BMI ≥18 \< 30 kg/m2. 3) Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant, must be willing to use acceptable effecti...
B: FMXIN002 is being developed for anaphylaxis, a severe and potentially life-threatening allergic reaction. It is an investigational small molecule studied as an intranasal epinephrine product. Nasus Pharma Ltd. is developing it, and it has completed a Phase 1 clinical trial in healthy adult volunteers.
B: FMXIN002 is developed by Nasus Pharma Ltd., which trades under the ticker NSRX. The company is advancing the asset as an intranasal epinephrine candidate for anaphylaxis. Development so far includes one completed Phase 1 clinical trial conducted in Israel.
B: FMXIN002 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a comparative bioavailability trial of intranasal epinephrine that enrolled 12 healthy adult volunteers in Israel.
B: FMXIN002 has been studied in one completed clinical trial, NCT06205134, titled Comparative Bioavailability of Intranasal Epinephrine. The Phase 1 study enrolled 12 healthy adult volunteers in Israel, was randomized and controlled, and evaluated participants with conditions listed as anaphylaxis and anaphylactic reaction.