Insignis Therapeutics and HLK Pharmacin Receive FDA IND Clearance to Initiate a Phase 1 Trial With IN-001 for Oral Anaphylaxis Treatment

Trial to initiate this quarter with data anticipated in 2021

Convenient oral alternative to injectable epinephrine

NORTH HAVEN, Conn. and NEW HAVEN, Conn., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Insignis Therapeutics (“Insignis”), a biotech company focused on developing innovative therapeutics for anaphylaxis treatment and HLK Pharmacin, a global drug development company, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IN-001, an oral formulation of an epinephrine prodrug for life-saving treatment of allergic reactions, including anaphylaxis. Under this IND, Insignis in collaboration with its strategic partner, HLK Pharmacin, is prepared to initiate a Phase 1 study with IN-001 (known as HLK-0006 within HLK Pharmacin) and intends to have clinical data in first half of 2021.

The Phase 1 single dose study in healthy volunteers will compare IN-001 orally dissolving tablet (epinephrine prodrug) vs the current standard of care, EPIPEN (epinephrine injection). If successful, under the 505(b)(2) regulatory pathway, Insignis and HLK Pharmacin would begin preparations to initiate a pivotal study in the second half of 2021.      

“The FDA clearance of our IND represents an important milestone for Insignis and our strategic partner HLK Pharmacin as we advance the development of IN-001 to provide people living with severe allergies an oral prodrug version of epinephrine for life-threatening emergencies such as when anaphylaxis strikes,” commented Mingbao Zhang, PhD, Chief Executive Officer and Founder of Insignis Therapeutics. “The global anaphylaxis injectable epinephrine market is a multi-billion dollar opportunity that is continuing to grow with the increase in prevalence and incidence of anaphylaxis. We believe that IN-001 has the potential to provide patients with a more discreet, convenient and fast acting alternative to current emergency injectable treatment options.”

HLK Pharmacin CEO and Co-Founder Ms. Jun Xu commented, “As a strategic collaborator, we are very pleased with the FDA IND clearance. We believe IN-001 has the potential to be a transformative treatment for anaphylaxis since it is a patient compatible, oral formulation and eliminates the need for an injectable product.”

IN-001 is a fast acting, orally dissolving tablet formulation that doesn’t require water or swallowing, potentially allowing rapid administration of life-saving epinephrine by anyone, anywhere and anytime. As an ambient, temperature stable oral prodrug form of epinephrine, IN-001 provides benefits over the current injectable formulation including ease of use, accessibility and longer shelf life.

Julie Wang, MD, Professor of Pediatrics at Mont Sinai School of Medicine, and Scientific Advisor to Insignis Therapeutics, commented, “Epinephrine is the key treatment for anaphylaxis. However, the inconvenience of carrying autoinjectors and fear of needles are known barriers to timely administration of this life-saving medication. A patient friendly alternative to injectable epinephrine can reduce treatment delays, and the IN-001 orally dissolving tablet has the potential to address this critical need.”  

About Insignis Therapeutics
Insignis Therapeutics is a North Haven, CT based biotech company focused on developing innovative therapeutics for anaphylaxis treatment. Its lead drug candidate, IN-001, is an orally dissolving tablet of epinephrine prodrug that provides patients with a convenient oral option over currently available injectable epinephrine for life-threatening allergic emergencies. The Company has received US FDA clearance of its IND application and is preparing to initiate a Phase 1 study to evaluate the use of IN-001 for anaphylaxis. For more information visit

About HLK Pharmacin
HLK Pharmacin is a global drug development company based in New Haven, CT with corporate headquarters in Shenzhen, China. HLK Pharmacin is committed to improving patient outcomes through the development of best-in-class therapeutics. From concept through commercialization, HLK Pharmacin deploys state-of-the-art technology to enable value-added medicines to be realized faster and more cost effectively. For more information visit

Company Contact:
Mingbao Zhang, PhD

Back to news