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Insignis Therapeutics

North Haven, Connecticut, United Statesinsignisrx.com ↗

Ownership: Private
Development stage: Phase 2

Overview

Insignis Therapeutics’ lead candidate, IN-001 (OSEPI), is a needle-free epinephrine sublingual spray for emergency treatment of anaphylaxis. In October 2024, positive results from a Phase 1 study showed that IN-001 was safe and well-tolerated with only mild, transient adverse events. The FDA granted Fast Track designation to the program in July 2024 due to its potential to address unmet needs in anaphylaxis management. The product remains stable under extreme temperatures and offers advantages over traditional auto-injectors.

Therapeutic areas: Immunology
Modalities: Small moleculeProdrug (epinephrine prodrug)Sublingual spray delivery system
Industry: Biotech

Drug pipeline

1 asset

HLK-0006

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