Tag: Investigational New Drug Application (IND)

Aquestive AQST-109 Epinephrine Film

Aquestive Reports Positive Results from Sublingual Epinephrine Clinical Trial

Phase 2 study continues to show AQST-109 is safe and well tolerated.
Test Tubes

FDA Green Lights Phase 2 Trials of PVX108, a Novel Peptide-Driven...

Phase 2 study of candidate from Aravax will commence in the US and Australia.
Aquestive's Subingual Epinephrine

Aquestive’s Sublingual Epinephrine Achieves Therapeutic Blood Concentrations Following Administration

Company presented top level Phase 1 results at #AAAAI2022 meeting.
Moonlight Therapeutics Microneedle Patch

Study Finds Microneedle Delivery Successful in Test of Peanut Allergy Immunotherapy

Study finds five-minute weekly dose of peanut protein through the skin, delivered by a novel microneedle technology, was superior in desensitizing peanut-allergic mice compared to administering the protein through a skin patch.
Moonlight Therapeutics Microneedle Patch

Microneedle Dermal Stamp to Treat Peanut Allergy Takes Another Step Forward

Moonlight Therapeutics received FDA guidance for first in-human clinical trial of MOON101.
COUR Nanoparticle

FDA Accepts Investigational New Drug Application for Novel Peanut Allergy Therapy

The company, which is already in phase 2 clinical trials with a treatment for celiac disease, has announced the FDA has accepted their Investigational New Drug (IND) application for evaluation of CNP-201, A treatment for peanut allergy. that reduces the need for strict peanut avoidance and reduces the potentially fatal health risks associated with peanut allergy.
Aquestive's Subingual Epinephrine

Aquestive Charts Ambitious Path Forward for Sublingual Emergency Epinephrine

Company updates the public on status of their candidate drug administered under the tongue.
Peanut Allergy Vaccine

Peanut Allergy Vaccine Takes Another Step with Biomarker Study

Study will help establish the starting dose of its vaccine candidate for a subsequent in-human phase I study.
Child Brushing Teeth

Toothpaste Therapy for Food Allergies Takes Another Step Forward

FDA accepts IND application by Intrommune Therapeutics.