A Phase 1 study with IN-001 in healthy volunteers
Latest Information Update: 05 Nov 2020
At a glance
- Drugs Dipivefrine (Primary) ; Epinephrine
- Indications Anaphylaxis
- Focus Adverse reactions
- 05 Nov 2020 New trial record
- 29 Oct 2020 According to an Insignis Therapeutics media release, if this study is 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.
- 29 Oct 2020 According to an Insignis Therapeutics media release, the company and HLK Pharmacin 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, the companies are prepared to initiate a Phase 1 study this quarter and intends to have clinical data in first half of 2021.