Arcadia Medicine Announces FDA Clearance of IND Application for a Patented Form of MDMA

SAN FRANCISCO, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcadia Medicine (‘Arcadia’), a company developing safer empathogens to treat mental health disorders, has announced that the United States Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application. Arcadia now plans to initiate a clinical trial of AM-1002, its patented, non-racemic form of MDMA.

The IND is part of a pattern of progress on multiple fronts. Arcadia has raised $9.25M from investors including Sam Altman, Fred Ehrsam, and Dylan Field. The company has also secured a patent for AM-1002, underscoring the company’s strong intellectual property (IP) strategy and its extensive research on the power that these compounds hold to save lives and address the ongoing mental health crisis and its effects worldwide. Arcadia holds a Composition of Matter IP for non-racemic MDMA, which grants Arcadia the exclusive rights to a specific drug formulation. Its unique differentiators from traditional MDMA include:

Engineered for an optimal effect: Designed to selectively release serotonin and oxytocin, which drive its therapeutic effect without significant stimulant effects, that are known to drive addiction and hyperthermia.
Non-neurotoxic/lowered side effects: AM-1002 has been developed to be non-neurotoxic and is not expected to cause hyperthermia, a common side effect of MDMA. Furthermore, AM-1002 is designed to have fewer potential cardiovascular side effects compared to MDMA.
Flexible dosing: A potential for a wider range of safe doses would allow for more precise therapy and ongoing treatment options.

"Arcadia’s innovative work in developing a safer form of MDMA is an important step towards a potentially transformative psychiatric treatment" said Sam Altman, co-founder and CEO of OpenAI.

“At Arcadia, we’re creating an improved version of MDMA by redesigning the molecule to have an enhanced safety profile and a more targeted therapeutic effect, and this IND is a testament to our progress,” said Nikita Obidin, founder and CEO of Arcadia Medicine. “We plan to initiate a clinical trial of AM-1002 in Generalized Anxiety Disorder. We will also continue developing our broader pipeline of safe and effective mental health therapeutics, delivering them to patients across the globe with an ultimate goal of using them in a maximally flexible context, such as at-home prescription use.”

“Few take the challenge of improving the human experience head on. I am excited to support Arcadia in their development of non-neurotoxic MDMA,” said Fred Ehrsam, co-founder of Coinbase.

Arcadia plans to initiate clinical-stage activities for AM-1002 this year. In parallel, the company will continue to expand its pipeline of mental health therapeutics, with a focus on safe and efficacious entactogenic agents with mild psychoactive effects and minimal abuse liability.

About Arcadia Medicine
Arcadia Medicine is a San Francisco-based company developing safe entactogens to treat mental health disorders such as Generalized Anxiety Disorder (GAD), Post Traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and Substance Use Disorder (SUD). The company is engineering molecules to improve the clinical efficacy of promising compounds while reducing physical and psychological risks. Arcadia’s lead candidate is AM-1002, a patented, non-racemic version of MDMA. Arcadia’s secondary candidates include AM-1004, a mildly entactogenic antidepressant designed for self-administration as an alternative to SSRIs and SNRIs, and AM-1006, a short-acting, subperceptual psychoactive compound intended for use in a traditional hour-long therapeutic setting. The company is on a mission to scale safe and effective mental health therapies to reach patients in need.

For more information, go to https://arcadiamedicine.com/

For inquiries, please contact hello@arcadiamedicine.com

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