Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as FMXIN002 single dose
FMXIN002 · 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 is an investigational small molecule being developed by Nasus Pharma Ltd. for anaphylaxis, a severe and potentially life-threatening allergic reaction. It is in Phase 1 clinical development and has not been approved by the FDA. It is also referred to as FMXIN002 single dose.
FMXIN002 is being developed for the treatment of anaphylaxis, a serious allergic reaction. It is an investigational therapy in Phase 1 testing and is not yet approved for any indication. Its development sits within the immunology therapeutic area.
FMXIN002 is being developed by Nasus Pharma Ltd., which trades under the ticker NSRX. The company is running the clinical program for the asset in anaphylaxis.
FMXIN002 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. One trial is currently active and enrolling, with no completed trials to date.
FMXIN002 is being studied in trial NCT07228325, titled Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis. The Phase 1 trial is controlled, randomized, and enrolling by invitation, with a planned enrollment of 50 participants in Canada.
Yes, FMXIN002 single dose is another name used for FMXIN002. Both refer to the same investigational small molecule developed by Nasus Pharma Ltd. for anaphylaxis, currently in Phase 1 testing.