According to Nasus Pharma, the FDA has cleared an IND for a study of Nasus’s NS002 intranasal dry powder epinephrine for the treatment of anaphylaxis. Nasus says that it also plans to initiate a pivotal trial of NS002 by the end of 2026, with topline data expected to be available in early 2027.
In March 2026, Nasus announced that a Phase 2 trial of NS002 versus EpiPen intramuscular epinephrine “demonstrated multiple significant advantages for NS002, including a significantly faster time to the 100 pg/mL plasma epinephrine threshold. NS002 is delivered via Aptar Pharma‘s Unidose nasal powder delivery device. In October 2025, Nasus announced that it had acquired a license to use the UDS device through to potential commercialization of NS002.
Nasus Pharma CEO Brendan O’Grady commented, “FDA clearance of our IND for NS002 is a major development milestone for Nasus and represents a significant step toward the commercialization of this promising asset in a growing $2 billion market. Patients living with severe allergies today rely almost exclusively on needle-based autoinjectors. Based on the results from our recent Phase 2 study . . . we believe NS002 presents an opportunity to address a significant unmet medical need for these patients. In a market currently dominated by injectables, NS002’s rapid onset and intranasal administration offer patients and caregivers a potentially superior alternative for treating severe allergic reactions. FDA clearance of our IND application brings us one step closer to offering that alternative to the millions of people at risk of anaphylaxis.”
Read the Nasus Pharma press release
