Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMXIN002 single dose · 1 trial · 2 indications
Measurements in 14 timepoints
Time to maximum epinephrine level in plasma
Time to reach epinephrine level of 100pg/ml in plasma
Maximum epinephrine level in plasma
Total exposure to epinephrine
Pharmacodynamic response to epinephrine
Pharmacodynamic response to epinephrine
Pharmacodynamic response to epinephrine
| Arm | Type | Description |
|---|---|---|
| FMXIN002 Repeated doses in the same nostril | EXPERIMENTAL | Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart. |
| FMXIN002 Repeated doses in the opposite nostril | EXPERIMENTAL | Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart. |
| Name | Type | Description |
|---|---|---|
| FMXIN002 single dose | DRUG | Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions. |
| Epinephrine autoinjector single dose | DRUG | Epinephrine IM autoinjector 0.3mg |
| FMXIN002 single dose + NAC | DRUG | Single dose of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge (NAC) |
| Epinephrine autoinjector double dose | DRUG | Repeated doses of Epinephrine IM autoinjector 0.3mg, 10 minutes apart |
| FMXIN002 double dose | DRUG | Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, at normal conditions, 10 minutes apart. |
| FMXIN002 double dose + NAC | DRUG | Double doses of FMXIN002 epinephrine microspheres powder for nasal application, 4.0 mg, after Nasal Allergenic Challenge, 10 minutes apart. |
Inclusion Criteria: 1. Non-smoking, male and female participants, from 18 to 55 years of age. 2. Documented positive skin allergy test at screening. 3. History of hay fever, seasonal allergies, or allergic rhinitis during the last year. 4. BMI ≥18 and \< =30 kg/m2. 5. Females may be of childbearing...
FMXIN002 single dose is an investigational small molecule being developed for anaphylaxis, a severe and potentially life-threatening allergic reaction. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy adults with allergic rhinitis to evaluate its pharmacokinetics and pharmacodynamics.
FMXIN002 single dose is being developed by Nasus Pharma Ltd., a biopharmaceutical company. The company is publicly traded under the ticker symbol NSRX. Nasus Pharma is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of anaphylaxis.
FMXIN002 single dose is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is designed to assess the drug's pharmacokinetics and pharmacodynamics in healthy volunteers.
FMXIN002 single dose is being studied in one active Phase 1 clinical trial with the identifier NCT07228325. This trial, titled 'Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis,' is enrolling 50 participants in Canada. The study is enrolling by invitation and includes healthy volunteers aged 18 years and older.
FMXIN002 single dose is a small molecule being developed for anaphylaxis. The specific molecular target and mechanism of action have not been disclosed in available information. The drug is being studied to understand its pharmacokinetics and pharmacodynamics compared to EpiPen in healthy adults with allergic rhinitis.