major depressive disorder

The U.S. Food and Drug Administration (FDA) has offered positive feedback to CaaMTech, Inc. on its CT-4201 psilocin prodrug program, specifically endorsing the company's approach to addressing "functional unblinding" in its drug trials. This regulatory milestone not only clears the clinical...

Cybin Inc. (AMEX:CYBN) has launched its Phase 3 pivotal program called PARADIGM, which is aimed at testing the efficacy of its lead candidate, CYB003, for treating Major Depressive Disorder (MDD) in a move that comes after three years of development. "Just three years after filing an...

The UK-based psychedelics medicine company Beckley Psytech announced Thursday that it has dosed its first patients in a Phase IIa study (NCT05434156) of ELE-101, a patent-protected synthetic formulation of psilocin benzoate to treat major depressive disorder (MDD). Psilocin is the active metabolite...

Australian biopharma company MindBio Therapeutics Corp. has shared positive topline results from its completed take-home microdosing clinical trial on major depressive disorder.  The treatment provided to the 20 participants is MB22001, the company's microdose formulation of a self-titratable...

Psychedelics company Cybin Inc. (NYSE: CYBN) shared its Phase 2 study interim results for its psilocybin analog CYB003 on Major Depressive Disorder (MDD) paired with the company’s EMBARK psychotherapy.  The new data met the trial’s primary efficacy endpoint: A rapid, robust...

Cybin Inc. (NYSE: CYBN), a clinical-stage biotech company developing novel psychedelic-based mental health treatments, has completed dosing of the final participant cohort in the Phase 2 study on its deuterated psilocybin analog CYB003 assessed for Major Depressive Disorder (MDD) treatment....

New findings on safety, tolerability and efficacy from a clinical study assessing the interaction of psychedelics and traditional pharma for the treatment of major depressive disorder (MDD) are out. They correspond to U.K.’s short-acting psychedelic therapies developer Small Pharma’s (...

Clinical-stage psychedelics biotech Cybin (NYSE: CYBN) has completed enrollment in its Phase 2 study of novel deuterated psilocybin analog CYB003 for the potential treatment of Major Depressive Disorder (MDD.)  All participants in the sixth and final cohort have reportedly received at least...

Nonprofit medical research organization the Usona Institute shared the results from its Phase 2 trial assessing a single 25mg synthetic psilocybin dose for 104 adults with Major Depressive Disorder (MDD,) providing further evidence of the psychedelic’s antidepressant capabilities. Led by...

Clinical-stage biopharma company Cybin Inc. (NYSE: CYBN) has completed participant dosing on the part 2 of 3 of its Phase 1 trial assessing intravenous (IV) administration of proprietary DMT drug CYB004. While the trial evaluates safety and efficacy of escalating doses of DMT and CYB004 in healthy...

Psychedelics biopharma company Mind Medicine Inc.’s (NASDAQ: MNMD) shared positive topline data from an advanced clinical trial evaluating its lysergide (aka LSD) for the treatment of Major Depressive Disorder (MDD) on Friday — just a couple of days before the 80th anniversary of...

Results from an advanced clinical trial assessing psilocybin-assisted therapy for patients with cancer and Major Depressive Disorder (MDD) conducted by oncology center Sunstone Therapies were published in the acclaimed JAMA Oncology. The open-label Phase 2 study tested psilocybin paired with ...

Short-acting psychedelics company Small Pharma Inc. (OTCQB: DMTTF) has shown positive outcomes from a six-month follow-up of its Phase 2a clinical trial of proprietary DMT compound SPL026 for the treatment of Major Depressive Disorder (MDD.)  The trial assessed the safety...

Biotech company FSD Pharma Inc. (NASDAQ: HUGE)’s Australian business FSD Pharma Australia Pty Ltd. has been approved by the Alfred Ethics Committee to begin a Phase 1 clinical trial of next-gen drug candidate Lucid-201, or Lucid-Psych, for cases of Major Depressive Disorder (MDD.) ...

Short-acting psychedelics biotech company Small Pharma Inc. (OTCQB: DMTTF) shared positive outcomes from its Phase 2a study of SPL026, the first placebo-controlled trial of the DMT-based short-duration psychedelic compound for the treatment of Major Depressive Disorder (MDD).  The trial...