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Nasus Pharma Announces FDA Clearance to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis

$NSRXPress releaseSep 14, 2026, 8:00 AM ETRead the release

Nasus Pharma received FDA clearance of its Investigational New Drug application for NS002, an investigational intranasal epinephrine powder positioned as a needle-free alternative to EpiPen for treating anaphylaxis. The pivotal study is planned to start in the fourth quarter of 2026 with topline data anticipated in the first quarter of 2027, and will compare self-administration to administration by a health care professional.

Key figures

Drug Name
NS002 (investigational intranasal epinephrine powder)
Phase Of Trial
Pivotal study planned for Q4 2026; topline data anticipated Q1 2027
Market size
$2 billion
Prior study
Phase 2
Median t100 ns002 minutes
1.69
Median t100 epipen minutes
3.47
Epinephrine plasma threshold pg ml
100

AI analysis

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    NSRX: Nasus Pharma Announces FDA Clearance to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis — AI Analysis | Signal8