TEL AVIV, Israel — September 14, 2026
Nasus Pharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application for NS002, an investigational intranasal epinephrine powder being developed for the treatment of anaphylaxis. The regulatory clearance enables Nasus Pharma to advance NS002 into clinical development in the United States and represents a key milestone for the company’s strategy to develop needle-free intranasal therapies. The company plans to initiate its pivotal study in the fourth quarter of 2026, with topline results anticipated in the first quarter of 2027. The clinical program is designed to evaluate NS002 as a potential alternative to conventional needle-based epinephrine delivery, while also assessing self-administration compared with administration by a healthcare professional. For Nasus Pharma, the FDA clearance moves its lead candidate closer to a pivotal development stage and potential commercialization in the anaphylaxis treatment market.
NS002 Builds on Phase 2 Epinephrine Data
NS002 is designed to deliver epinephrine through the nasal route using Nasus Pharma’s proprietary intranasal powder technology, potentially eliminating the need for an injection during an acute allergic reaction. The company’s development strategy is supported by results from a recent Phase 2 study, in which NS002 achieved the 100 pg/mL plasma epinephrine threshold considered critical by the company, with a median T100 of 1.69 minutes, compared with 3.47 minutes for EpiPen®. Nasus Pharma believes the rapid systemic exposure demonstrated in the Phase 2 program could support further evaluation of NS002 as a treatment option for severe allergic reactions. The company is now transitioning from earlier clinical evaluation toward its planned pivotal study, where the focus will shift toward generating the clinical evidence required to support potential regulatory and commercial development. The intranasal approach is particularly relevant in anaphylaxis, where rapid epinephrine administration is essential and patients or caregivers may face challenges using injectable devices.
Pivotal Study Targets Needle-Free Anaphylaxis Treatment
The planned pivotal study represents the next major clinical milestone for NS002, with initiation targeted for the fourth quarter of 2026 and topline data expected in the first quarter of 2027. The program will evaluate the investigational treatment in patients experiencing anaphylaxis and will compare self-administration with administration by a healthcare professional, addressing an important practical aspect of emergency treatment. Current severe-allergy management relies heavily on injectable epinephrine delivered through autoinjectors, creating an opportunity for alternative delivery technologies that may be easier for patients and caregivers to use. Nasus Pharma is positioning NS002 around its combination of intranasal administration and rapid epinephrine exposure, although the pivotal study will be important in determining whether these characteristics translate into an approvable and commercially competitive product. The company estimates that the broader anaphylaxis market represents an opportunity of approximately $2 billion, highlighting the commercial significance of successfully advancing a needle-free epinephrine product.
Advertisement
Nasus Pharma Expands Intranasal Drug Delivery Platform
The NS002 program also serves as the lead clinical application of Nasus Pharma’s proprietary intranasal powder technology platform, which the company is using to develop additional products across multiple therapeutic areas. Beyond epinephrine for Type I allergic reactions and anaphylaxis, Nasus Pharma aims to build a broader pipeline of differentiated intranasal drug-delivery candidates designed around rapid, reliable and patient-friendly administration. FDA clearance of the NS002 IND strengthens the company’s clinical development position and provides a pathway toward the planned pivotal study and potential future commercialization. The upcoming trial will be closely watched for evidence supporting the product’s pharmacokinetic performance, usability and clinical development strategy. With pivotal testing planned for late 2026 and topline results expected in early 2027, Nasus Pharma is positioning NS002 as the central driver of its near-term clinical and commercial strategy in needle-free anaphylaxis treatment.
Source: Nasus Pharma, press release
