Incannex To Prepare FDA IND Application For Psilocybin-Assisted Psychedelic Psychotherapy
Portfolio Pulse from Vuk Zdinjak
Incannex Healthcare Limited's subsidiary, Psychennex Pty Ltd, has begun preparations for an investigational new drug (IND) application to the U.S. FDA for its psilocybin assisted psychotherapy development program, Psi-GAD. The IND application is a key regulatory approval required to undertake clinical trials in the U.S. The company expects final clinical trial results from the Psi-GAD clinical trial in Q4 2023 or Q1 2024. The IND submission will include detailed modules on the safety and efficacy of psilocybin assisted psychotherapy across a range of mental health indications.
August 24, 2023 | 1:15 pm
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Incannex Healthcare is preparing an IND application to the FDA for its psilocybin assisted psychotherapy program. This is a key step towards conducting clinical trials in the U.S. The final results of the clinical trial are expected in Q4 2023 or Q1 2024.
The news is directly related to Incannex Healthcare and its subsidiary, Psychennex. The preparation of an IND application to the FDA is a significant step towards conducting clinical trials in the U.S. This could potentially lead to the approval of their psilocybin assisted psychotherapy program, which would be a significant milestone for the company. Therefore, this news is likely to have a positive impact on the company's stock in the short term.
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