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NCT04696822
Bioavailability of Nasal Epinephrine
Phase 1 trial testing Epinephrine Nasal Product, 1.6 mg in Anaphylaxis in 12 participants. Completed in 28 September 2021.
28 September 2021
Quick facts
| Lead sponsor | Nasus Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 November 2020 |
| Primary completion | 28 September 2021 |
| Estimated completion | 28 September 2021 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Epinephrine Nasal Product, 1.6 mg — full drug profile →
- Epinephrine nasal product, 1.6 mg + allergen — full drug profile →
- Epinephrine Injection 0.3 mg — full drug profile →
- Epinephrine Nasal Product, 3.2 mg — full drug profile →
- Epinephrine Nasal Product, 3.2 mg + allergen — full drug profile →
Conditions studied
- Anaphylaxis — all drugs for Anaphylaxis →
Sponsor
Nasus Pharma — full company profile →
Who can join
Adults 18 to 55, any sex, with Anaphylaxis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
First-in-class intranasal epinephrine spray for anaphylaxis: Dose finding clinical study.
Lapidot T, Tal Y, Megiddo D, Krayz GT, et al · · 2025 · PMID 40497018 · DOI 10.1016/j.jacig.2025.100487
Verify or expand the search:
- PubMed search for NCT04696822
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Anaphylaxis
Currently open trials in the same condition.
- NCT07210320 — PK/PD Study of IN-001 Sublingual Spray in Healthy Adults · Phase 1 · recruiting
- NCT07328178 — Analysis of the Role of IgE Proteoforms in Health and Disease · recruiting
- NCT05135377 — Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction · active not recruiting
- NCT04615065 — Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine · recruiting
- NCT03182491 — Mechanisms of Anaphylaxis · active not recruiting
Other Nasus Pharma trials
Trials by the same sponsor.
- NCT07045701 — FMXIN002 in Patients at Risk of Anaphylaxis · Phase 2, PHASE3 · enrolling by invitation
- NCT06205134 — Comparative Bioavailability of Intranasal Epinephrine · Phase 1, PHASE2 · completed
- NCT05252468 — COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19). · NA · completed
- NCT04713709 — A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04696822 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nasus Pharma
- Last refreshed: 5 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04696822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing