Breakthrough 5-MeO-DMT Therapy · Shangriballa

Breakthrough 5-MeO-DMT Therapy

"Last week, the U.S. Food and Drug Administration (FDA) awarded the groundbreaking therapy designation to 5-MeO-DMT of the toad poison alvarius, in a significant breakthrough for psychedelic medicine."

The designation was awarded to BPL-003, a new intranasal formulation of 5-MeO-DMT developed by Atai Life Sciences and Beckley Psytech.

The regulatory body's decision aims to accelerate the development of BPL-003 as a treatment for adults with treatment-resistant depression (TRD), a condition that affects up to 30% of the 280 million people worldwide living with depression.

The FDA decision comes after promising results of a Phase 2b clinical trial, which demonstrated that a single dose of BPL-003 produced rapid and sustained reductions of depressive symptoms within 24 hours, with effects lasting up to eight weeks. It should be noted that most participants were ready for discharge just 90 minutes after treatment, which highlights the potential of a scalable treatment model in the clinic.

5-MeO-DMT is a natural psychedelic compound present in several species. Its best-known presence can be found in the venom Incilius alvarius (Sonora desert frog), as well as other Bufo frogs. It is also found in certain plants, such as Virola and Anadenanthera peregrina species.

Companies claim that BPL-003 is designed to provide fast and lasting antidepressant effects with a single dose and a short therapeutic experience. Innovative Therapy designation facilitates intensive FDA guidance to support development of BPL-003. Phase 3 trials are expected to begin in the second quarter of 2026, subject to FDA approval.

Other innovative therapies designations in psychedelic compounds:

The FDA has previously awarded groundbreaking therapy designations to other psychedelic compounds, highlighting the growing recognition of psychedelics in mental health treatment:

Psilocybin: In 2018, the FDA awarded psilocybin the groundbreaking therapy designation for the treatment of treatment-resistant depression. In 2019, he received a second designation for major depressive disorder.

MDMA: In 2017, the FDA designated MDMA as an innovative therapy for the treatment of post-traumatic stress disorder (TEPT).

LSD: In March 2024 the FDA awarded the groundbreaking therapy designation to an LSD compound for the treatment of Generalized Anxiety Disorder (TAG), based on data from Phase 2b trials showing rapid and sustained improvements in anxiety symptoms.

Global Overview of 5-MeO-DMT Research

Beyond BPL-003, several organizations are exploring the therapeutic potential of 5-MeO-DMT:

Usona Institute has completed a phase 1 study of 5-MeO-DMT and is currently analyzing the results.

GH Research is currently studying a 5-MeO-DMT compound for treatment-resistant depression and is in phase 2 trials.

These initiatives reflect a global interest in harnessing the therapeutic potential of 5-MeO-DMT for various mental health conditions.

The FDA’s groundbreaking therapy designation for BPL-003 marks a milestone in the development of psychedelic treatments for mental health disorders. With clinical trials underway and growing regulatory support, the 5-MeO-DMT is profiling itself as a promising candidate in the changing landscape of psychiatric medicine. "

https://psychedelichealth.co.uk/2025/10/22/fda-grants-breakthrough-therapy-designation-to-beckley-and-atais-5-meo-dmt-program/?fbclid=IwdGRzaANq56dleHRuA2FlbQIxMQABHlY4rNI5CuEQbo38oYhrP041bbSX1IPl00wMDseG6B4LriDpGBRvIo59QFZP_aem_IgyXGLtBMQNsKOrhwxCHAQ&_hsenc=p2ANqtz-8A3nOR2-tzcqNHOtLT0y7tq3K8TOIxKrF_cr9SZ3Jym11h6CpDdMQwAz3i7D-GlNh9gwOwS0zBAoMidTpSMNORFyykeJaw-wXUE31wcUb51qiAsaA&_hsmi=120239023&utm_content=buffer6bc05&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer

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