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Resilient Pharmaceuticals

Also known as: Lykos Therapeutics, MAPS PBC, MAPS Public Benefit Corporation

San Jose, CA, United States
1 Drug Candidate3 Trials3 Papers

Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS (Multidisciplinary Association for Psychedelic Studies) as a commercial spinout to carry MAPS’ three decades of MDMA research through late-stage trials and regulatory approval. After completing two Phase 3 trials and filing an NDA in 2024, the FDA issued a Complete Response Letter (CRL) in August 2024, citing concerns about functional unblinding, durability of response, safety reporting at two trial sites, and the challenge of blinding psychedelic studies. The CRL requested a third Phase 3 trial. Following the rejection, the company laid off approximately 75% of staff. In May 2025, billionaire investors Antonio Gracias (Gracias Foundation) and Sir Christopher Hohn (TCI Fund) led a $50 million Series B recapitalisation, installing new leadership: CEO Mike Burke and CMO Javier Muniz. Rick Doblin, MAPS’ founder, remains supportive of the new direction. The company rebranded from Lykos Therapeutics to Resilient Pharmaceuticals on 28 August 2025, and continues to negotiate a path to FDA approval for MDMA-assisted therapy for PTSD.

Drug Pipeline

1

Midomafetamine (MDMA)

MDMA
FDA Review / NDA Filed
PTSD

MDMA-assisted therapy for PTSD. Phase 3 completed (two trials: MAPP1 and MAPP2). NDA submitted 2024; FDA issued Complete Response Letter (CRL) August 2024 citing functional unblinding, durability of response, and site-level safety reporting concerns. FDA requested a third Phase 3 trial prior to resubmission. Company restructured in 2025 and continuing to pursue approval.

Quick Facts

Type
biotech
Founded
2014
Lead Stage
FDA Review / NDA Filed
HQ
San Jose, CA, United States

Sponsored Trials

2
CompletedIII

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

Start Date
Compounds
MDMA, Placebo
CompletedII

Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

Start Date
Compounds
MDMA

Collaborated Trials

1
CompletedNA

Stanford Reward Circuits of the Brain Study – MDMA

Start Date
Compounds
MDMA, Placebo

Research Papers

3
Paywallindividual

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

This multi-site, randomised, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population.

Published
Journal
Nature Medicine
Authors
Balliett, B., Bogenschutz, M. P., de Boer, A., Doblin, R., Gelfand, Y., Hamilton, S., Harrison, C., Kleiman, S., Mitchell, J., Mithoefer, A. T., Nicholas, C. R., Ot’alora G, M., Paleos, C., Parker-Guilbert, K., Quevedo, S., Shannon, S., Tzarfaty, K., van der Kolk, B., Yazar-Klosinski, B.
Open Accessindividual

Long-term Follow-Up Outcomes of MDMA-assisted Psychotherapy for Treatment of PTSD: A Longitudinal Pooled Analysis of Six Phase 2 Trials

Pooled analysis of six phase 2 trials found that two to three MDMA‑assisted psychotherapy sessions produced large reductions in PTSD severity at 1–2 months (LS mean change −44.8; Cohen’s d = 1.58) with further small but significant improvement at least 12 months post‑treatment (LS mean change −5.2; d = 0.23). The proportion no longer meeting PTSD criteria rose from 56% at treatment exit to 67% at long‑term follow‑up, most participants reported lasting benefits (improved relationships and well‑being) and only a minority reported harms; phase 3 trials are underway to confirm these results.

Published
Journal
Psychopharmacology
Authors
Doblin, R., Emerson, A., Feduccia, A. A., Hamilton, S., Jerome, L., Mithoefer, M. C., Wang, J. B., Yazar-Klosinski, B.
Open Accessmeta

Breakthrough for trauma treatment: safety and efficacy of MDMA-assisted psychotherapy compared to paroxetine and sertraline

This review (2019) details the potential superiority of MDMA-assisted psychotherapy as a treatment for PTSD compared to the conventional treatment options paroxetine and sertraline.

Published
Journal
Frontiers in Psychiatry
Authors
Doblin, R., Emerson, A., Feduccia, A. A., Jerome, L., Mithoefer, M. C., Yazar-Klosinski, B.