Developer · RLMD · United States
Relmada Therapeutics, Inc.
Relmada Therapeutics is a NASDAQ-listed clinical-stage biotechnology company headquartered in Coral Gables, Florida, developing therapies for oncology and central nervous system disorders. Following the discontinuation of its lead depression candidate esmethadone (REL-1017) in 2025, its pipeline is led by NDV-01 (non-muscle invasive bladder cancer) and sepranolone (Tourette syndrome and compulsive disorders).
2compounds
2programs
2indications
Phase 2lead asset
Phase distribution
Modality
- neuroactive_steroid 1
- Small molecule 1
Mechanism focus
Pipeline (2)
- Tourette syndromePhase 2Completed
- Major depressive disorderDiscontinuedDiscontinued
Deals & partnerships
- Esmethadone (REL-1017)Licensor Charles E. Inturrisi, Ph.D.Licensor Paolo Manfredi, M.D.
- SepranoloneLicensor Asarina Pharma AB
- Feb 3, 2025Licensing dealRelmada acquires global rights to sepranolone from Asarina PharmaUnder an Asset Purchase Agreement finalized February 3, 2025 (announced February 6, 2025), Relmada acquired full global ownership rights to sepranolone, a Phase 2b-ready GABA-A pathway neurosteroid for Tourette syndrome and other compulsive disorders, from Sweden's Asarina Pharma AB for EUR 3 million. Relmada plans to advance sepranolone into a Phase 2b study in Tourette syndrome.
- Jan 2018Licensing dealRelmada in-licenses esmethadone (REL-1017) from inventors Inturrisi and ManfrediIn January 2018 Relmada entered an exclusive license agreement with Dr. Charles E. Inturrisi and Dr. Paolo Manfredi, the inventors of esmethadone (REL-1017, d-methadone/dextromethadone), licensing certain rights including patents and patent applications. Terms included a $180,000 upfront fee plus $45,000 quarterly payments continuing until commercialization or patent expiry. After three failed Phase 3 MDD studies, Relmada discontinued esmethadone development and delivered formal notice of termination of the license on July 7, 2025; all material obligations ceased October 5, 2025 (90 days later), with no termination fees.
Catalysts · 0 upcoming · 3 reported
Recently reported
- 2023-04-01mixed
SepranoloneforTourette syndromeTopline data
Sepranolone Phase 2a in Tourette syndrome: 28% YGTSS tic reduction vs 12.6% control (p=0.051); all secondary endpoints (PUTS, GTS-QOL, impairment) favored sepranolone; favorable safety.
- 2022-12-07missed
Esmethadone (REL-1017)forMajor depressive disorderTopline data
RELIANCE-I adjunctive missed its primary MADRS Day 28 endpoint (REL-1017 -15.1 vs placebo -12.9, not significant).
- 2022-10-13missed
Esmethadone (REL-1017)forMajor depressive disorderTopline data
RELIANCE-III monotherapy missed its primary MADRS Day 28 endpoint (REL-1017 -14.8 vs placebo -13.9).
Recent activity
- Jul 7, 2025Phase changeEsmethadone (REL-1017)·Major depressive disorderDiscontinuedRelmada terminated the esmethadone license agreement and returned the REL-1017 technology to its inventors (Charles Inturrisi & Paolo Manfredi / Levomecor Inc.), formally ending Relmada's REL-1017 development in MDD.source ↗
- Feb 6, 2025Phase changeSepranolone·Tourette syndromePhase 2Relmada Therapeutics acquired full global rights to sepranolone from Asarina Pharma (EUR 3M asset purchase); described as Phase 2b-ready for Tourette syndrome and other compulsion-related conditions.source ↗
- Apr 1, 2023ReadoutSepranolone·Tourette syndromemixedSepranolone Phase 2a in Tourette syndrome: 28% YGTSS tic reduction vs 12.6% control (p=0.051); all secondary endpoints (PUTS, GTS-QOL, impairment) favored sepranolone; favorable safety.source ↗
- Feb 1, 2023Phase changeSepranolone·Tourette syndromePhase 2Phase 2a Tourette study NCT05434546 reached primary completion (actual). Results published by Asarina Pharma 2023-04-01.source ↗
- Dec 7, 2022ReadoutEsmethadone (REL-1017)·Major depressive disordermissedRELIANCE-I adjunctive missed its primary MADRS Day 28 endpoint (REL-1017 -15.1 vs placebo -12.9, not significant).source ↗
- Oct 13, 2022ReadoutEsmethadone (REL-1017)·Major depressive disordermissedRELIANCE-III monotherapy missed its primary MADRS Day 28 endpoint (REL-1017 -14.8 vs placebo -13.9).source ↗
- Jan 8, 2021Phase changeEsmethadone (REL-1017)·Major depressive disorderPhase 3Phase 3 RELIANCE program initiated (RELIANCE-I adjunctive first patient; RELIANCE-II, RELIANCE-III monotherapy, and open-label safety studies followed in 2021).source ↗
- Sep 30, 2019Phase changeEsmethadone (REL-1017)·Major depressive disorderPhase 2Phase 2a, 7-day adjunctive proof-of-concept (NCT03051256, n=62, 25 or 50 mg/day) completed; reported rapid, robust, sustained antidepressant signal vs placebo, supporting advancement to Phase 3.source ↗
Competitive landscape
Other companies developing against Relmada Therapeutics, Inc.'s targets or indications.
- Seaport Therapeutics, Inc.1 compoundGABA-A receptorMajor depressive disorder
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Axsome Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
- Biohaven Ltd.1 compoundMajor depressive disorder
- Boehringer Ingelheim International GmbH2 compoundsMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.1 compoundMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorder
- CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.1 compoundMajor depressive disorder
- Definium Therapeutics, Inc.1 compoundMajor depressive disorder
- Delix Therapeutics, Inc.1 compoundMajor depressive disorder
