Lykos Therapeutics

What Lykos Therapeutics does

Lykos Therapeutics is a private, San Jose-based public benefit corporation founded in 2014 as MAPS Public Benefit Corporation by the Multidisciplinary Association for Psychedelic Studies (MAPS), and rebranded to Lykos Therapeutics in January 2024. The company is developing investigational MDMA-assisted therapy for post-traumatic stress disorder, combining the psychoactive compound MDMA with manualized psychotherapy sessions. Its core product candidate is a single-asset, single-indication psychedelic-assisted psychotherapy protocol that completed two positive Phase 3 readouts and became the first MDMA-assisted PTSD therapy to be submitted to the FDA as a New Drug Application; the FDA subsequently issued a Complete Response Letter in August 2024 citing data gaps and insufficient characterization of the psychotherapy component. Lykos also operated an FDA-authorized Expanded Access Program fully enrolled at up to 50 PTSD patients, and is building healthcare-provider training programs to prepare for a potential future commercial launch.\n\nLykos is pre-commercial and pre-revenue, with no approved product and no published pricing. The intended business model, once (and if) FDA approval is secured, is prescription pharmaceutical sales of MDMA-assisted therapy distributed through traditional pharmaceutical channels to PTSD patients, particularly those with treatment-resistant disease, and administered by specially trained therapists and psychiatrists. To date the company has raised over $100 million in an oversubscribed Series A led by Helena in January 2024, and announced a Series B first close in May 2025, providing the capital base to fund additional clinical work, regulatory resubmission, and pre-launch activities.

Name

Lykos Therapeutics

Legal name

Lykos Therapeutics

Website

https://lykospbc.com/

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

Lykos Therapeutics is a private, San Jose-based public benefit corporation developing investigational MDMA-assisted psychotherapy for post-traumatic stress disorder, currently pre-commercial following an FDA Complete Response Letter in August 2024, with two completed positive Phase 3 trials and ongoing regulatory resubmission efforts.

Ownership category

akta.pro rank

Product category

Psychiatric Pharmaceuticals

NAICS

Outpatient Mental Health and Substance Abuse Centers (621420), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), Services-Health Services (8000)

akta.pro primary industry

DTx/SaMD Deployment, Integration & Reimbursement Enablement (HLACANAO)

akta.pro secondary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

Keywords

• Psychedelic-assisted therapy
• MDMA pharmaceutical development
• PTSD clinical research
• Mental health therapeutics
• Investigational drug development

Headquarters

HQ city

San Jose

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Sales: Once FDA approval is obtained, Lykos expects to generate revenue through the sale of prescription MDMA-assisted therapy for PTSD. The company submitted a New Drug Application (NDA) to the FDA and is pursuing regulatory approval for market entry.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Lykos Therapeutics is a clinical-stage pharmaceutical company developing MDMA-assisted therapy as an investigational prescription treatment for post-traumatic stress disorder. The therapy combines the psychoactive compound MDMA with supervised psychotherapy sessions and is supported by Phase 3 clinical trial data. The company is also building therapist training programs to enable healthcare providers to deliver the protocol upon regulatory approval.

Product overview

Lykos Therapeutics is a pharmaceutical company developing investigational psychedelic-assisted therapies for mental health conditions. The company's primary product is MDMA-assisted therapy for PTSD, which combines MDMA administration with psychotherapy. This represents a single investigational therapeutic product currently undergoing regulatory review. The company was founded in 2014 by the Multidisciplinary Association for Psychedelic Studies (MAPS) as MAPS Public Benefit Corporation and rebranded to Lykos Therapeutics in January 2024. The company has completed Phase 3 clinical trials and submitted an NDA to the FDA, though the application was rejected in August 2024. Lykos also operated an expanded access program for up to 50 PTSD patients, which has been fully enrolled.

Differentiator

Problem solved

Functional benefit

Products and services

• MDMA-Assisted Therapy for PTSD Investigational prescription therapy combining MDMA (3,4-methylenedioxymethamphetamine) administration with supervised psychotherapy sessions, developed as a treatment for post-traumatic stress disorder in adults. The product completed two positive Phase 3 clinical trials, and an NDA was submitted to the FDA; however, the FDA issued a Complete Response Letter in August 2024 citing concerns about the application, including data gaps, inadequate study of misuse and addiction risks, and lack of evidence for the psychotherapy protocol. The therapy is intended for patients with PTSD, particularly treatment-resistant cases.

Quantifiable outcome

• Phase 3 trials showed positive results for MDMA-assisted therapy for PTSD treatment

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• MAPS (Multidisciplinary Association for Psychedelic Studies)coreStrategic or Co-development PartnerMAPS, a 501(c)(3) non-profit organization, founded Lykos Therapeutics (originally MAPS PBC) in 2014. MAPS has conducted decades of evidence-based research supporting the development of MDMA-assisted therapy for PTSD and remains the parent organization.

Scale indicators6 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Compass Pathways: Clinical-stage psychedelic therapeutics developer of COMP360 psilocybin therapy for treatment-resistant depression. Direct peer: both companies pursue FDA-regulated psychedelic-assisted psychotherapy for serious psychiatric indications, share similar regulatory pathway, clinical-stage profile, and capital markets dynamics.
• Atai Life Sciences: Clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic mental health therapeutics, with a portfolio of programs across depression, PTSD, and anxiety. Direct peer: overlapping psychedelic drug development platform, similar capital structure, and shared strategic focus on mental health innovation.
• MindMed: Clinical-stage psychedelic medicine company developing LSD-based therapies (MM-120) for anxiety and ADHD, plus other programs. Direct peer: psychedelic-assisted therapy developer pursuing FDA approval with similar regulatory, clinical, and commercial model to Lykos.
• GH Research: Clinical-stage biopharmaceutical company developing inhaled 5-MeO-DMT (GH001) for treatment-resistant depression. Direct peer: psychedelic drug developer focused on a single mental health indication with comparable regulatory pathway, clinical-stage status, and target market overlap.
• Cybin: Clinical-stage psychedelic therapeutics company developing deuterated psilocybin analog CYB003 for depression and other indications. Direct peer: psychedelic drug developer with overlapping regulatory and clinical development pathway in mental health.
• Small Pharma: Clinical-stage DMT-assisted therapy developer for major depressive disorder (SPL026). Direct peer: psychedelic-assisted psychotherapy developer using a short-duration psychedelic combined with therapy, paralleling Lykos's drug-plus-psychotherapy model.
• Beckley Psytech: Clinical-stage private psychedelic medicine company developing intranasal 5-MeO-DMT (BPL-003) and psilocybin programs for depression and other CNS indications. Direct peer: psychedelic drug developer with similar clinical stage and target indications.

Emerging players

• Field Trip Health: Operator of psychedelic-assisted therapy clinics (formerly) and developer of FT-104, a next-generation psychedelic compound. Emerging player: shared psychedelic-assisted therapy thesis, though Field Trip's emphasis was on clinic-based delivery rather than a single NDA-bound drug.

Broad incumbents

• Sage Therapeutics: Established CNS biopharmaceutical company that brought Zurzuvae (zuranolone) to FDA approval for postpartum depression. Broad incumbent: comparable business model as a focused CNS drug developer targeting serious psychiatric conditions, with far greater commercial maturity and approved-product revenue.
• Johnson & Johnson (Janssen): Large pharmaceutical company that commercialized Spravato (esketamine), the first FDA-approved psychedelic-adjacent therapy for treatment-resistant depression. Broad incumbent: the only competitor with an approved psychedelic-adjacent CNS product on the market, representing the established-pharma benchmark Lykos aspires to compete with.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/login
• Facebookfacebook.com/LykosTherapeutics
• LinkedInlinkedin.com/company/lykos-therapeutics
• Instagraminstagram.com/lykostherapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds3 records

Investors13 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lykos Therapeutics