Insignis Therapeutics
Insignis Therapeutics is a privately held specialty pharmaceutical company focused on developing innovative allergy and anaphylaxis treatments. The company is dedicated to creating groundbreaking, safe, and effective treatments such as the IN-001 liquid epinephrine sublingual spray, which aims to revolutionize the treatment of severe allergic reactions including anaphylaxis. Their mission is to develop oral versions of epinephrine auto-injectors to help people with severe allergies live with greater freedom and confidence. They leverage advanced technology and scientific expertise to improve the quality of life for patients worldwide through innovative, effective, and accessible medical solutions.
Industries
Nr. of Employees
small (1-50)
Insignis Therapeutics
Patents
Products
Investigational sublingual epinephrine liquid spray (investigational)
An investigational liquid formulation for sublingual administration of epinephrine (prodrug-based) housed in a unit-dose disposable spray device intended as an emergency rescue medication for anaphylaxis.
Investigational sublingual epinephrine liquid spray (investigational)
An investigational liquid formulation for sublingual administration of epinephrine (prodrug-based) housed in a unit-dose disposable spray device intended as an emergency rescue medication for anaphylaxis.
Services
Management and coordination of external CDMOs and CROs for API and drug product development to accelerate timelines to regulatory milestones.
Analytical method development, validation, stability determination, and CMC support to prepare for regulatory submissions and manufacturing readiness.
Design and sponsorship of early-phase clinical studies focused on PK/PD and safety to generate data for regulatory interactions.
Management and coordination of external CDMOs and CROs for API and drug product development to accelerate timelines to regulatory milestones.
Analytical method development, validation, stability determination, and CMC support to prepare for regulatory submissions and manufacturing readiness.
Design and sponsorship of early-phase clinical studies focused on PK/PD and safety to generate data for regulatory interactions.
Expertise Areas
- Clinical trial management
- Pharmacokinetics and PK/PD analysis
- Formulation development for sublingual delivery
- CMC and process chemistry
Key Technologies
- Sublingual liquid spray delivery
- Prodrug-based formulation
- Unit-dose disposable spray device
- PK/PD bioanalysis
News & Updates
The FDA grants Fast Track status to IN-001, a needle-free, stable, and easy-to-use liquid epinephrine spray for emergency treatment of anaphylaxis, addressing unmet medical needs.
Phase 1 clinical study demonstrates rapid absorption, sustained efficacy, and safety of IN-001, with superior performance compared to existing products.
The study showed rapid absorption within 9 minutes, plasma levels above 100 pg/mL for 2 hours, and a good safety profile.
The FDA grants Fast Track status to IN-001, a needle-free, stable, and easy-to-use liquid epinephrine spray for emergency treatment of anaphylaxis, addressing unmet medical needs.
Phase 1 clinical study demonstrates rapid absorption, sustained efficacy, and safety of IN-001, with superior performance compared to existing products.
The study showed rapid absorption within 9 minutes, plasma levels above 100 pg/mL for 2 hours, and a good safety profile.