Developer · ANRO · United States
Alto Neuroscience, Inc.
Alto Neuroscience is a U.S. clinical-stage biopharmaceutical company developing precision-psychiatry medicines for CNS disorders, using EEG and behavioral biomarkers to match in-licensed and acquired small-molecule candidates to patient subgroups in depression and related indications.
5compounds
5programs
4indications
Phase 2lead asset
Phase distribution
Modality
- Small molecule 5
Mechanism focus
- D3 1
- H3 receptor 1
- MT1 1
- Phosphodiesterase 4 1
- TLX 1
Pipeline (5)
- Bipolar depressionPhase 2Recruiting
- Major depressive disorderPhase 2Completed
- Treatment-resistant depressionPhase 2Recruiting
- Major depressive disorderPhase 2Active
- SchizophreniaDiscontinuedDiscontinued
Deals & partnerships
- ALTO-100 (amdiglurax)Partner The Wellcome Trust Limited
- ALTO-101Licensor SanofiPartner MedRx Co., Ltd.
- ALTO-203Licensor Teva Pharmaceutical Industries Ltd.Licensor Cephalon, Inc.
- ALTO-207Licensor Chase Therapeutics Corporation
- May 2025Licensing dealAlto acquires ALTO-207 (CTC-501) from Chase TherapeuticsIn May 2025, Alto Neuroscience acquired ALTO-207 (formerly CTC-501), a fixed-dose combination of pramipexole (dopamine D3/D2 agonist) and ondansetron (5-HT3 antagonist), from Chase Therapeutics Corporation for development in major depressive disorder.
- Jul 25, 2024PartnershipWellcome Trust funding award to advance ALTO-100 in bipolar depressionOn July 25, 2024, Alto Neuroscience announced a non-dilutive funding award from The Wellcome Trust Limited (up to approximately $11.7 million convertible funding) to support the Phase 2b study of ALTO-100 as an adjunctive treatment in bipolar depression using a precision-psychiatry biomarker approach.
- Sep 25, 2023Licensing dealAlto and MedRx joint development & license agreement for ALTO-101 transdermal formulationOn September 25, 2023, Alto Neuroscience entered into a Joint Development and License Agreement with MedRx Co., Ltd. for an exclusive, sublicensable, worldwide license to develop a transdermal formulation of the PDE4 inhibitor ALTO-101.
- Oct 4, 2021Licensing dealAlto acquires histamine H3 inverse agonist (ALTO-203) from Teva / CephalonAlto Neuroscience acquired patents, know-how and other rights to ALTO-203, an oral small-molecule histamine H3 receptor inverse agonist, from Teva Pharmaceutical Industries, Ltd. and its affiliate Cephalon, Inc., effective October 4, 2021.
- May 18, 2021Licensing dealAlto in-licenses PDE4 inhibitor (ALTO-101) from SanofiEffective May 18, 2021, Alto Neuroscience entered into a license agreement with Sanofi for an exclusive, worldwide, royalty-bearing license (with sublicense rights) under Sanofi patent rights and know-how relating to a PDE4 inhibitor compound now known as ALTO-101.
Catalysts · 2 upcoming
- 2026-04-01Anticipated
ALTO-101forSchizophreniaTopline data
- 2H 2027Anticipated
ALTO-207forTreatment-resistant depressionTopline data
ALTO-207 Phase 2b TRD topline (MADRS)
Recent activity
- Apr 21, 2026Phase changeALTO-207·Treatment-resistant depressionPhase 2Registration-enabling Phase 2b trial (NCT07553637) of ALTO-207 in TRD initiated; ~178 patients, 1:1 vs placebo, 8 weeks, MADRS primary endpoint; topline 2H 2027.source ↗
- Apr 1, 2026Phase changeALTO-101·SchizophreniaDiscontinuedPhase 2 POC missed primary EEG/cognitive endpoints vs placebo (theta-ITC d=0.34, p=0.052, n=83). Alto will not independently advance ALTO-101 in CIAS; exploring partnering; prioritizing ALTO-207.source ↗
- Oct 3, 2025Phase changeALTO-101·SchizophreniaPhase 2FDA granted Fast Track designation to ALTO-101 for cognitive impairment associated with schizophrenia (CIAS).source ↗
- Jun 26, 2025Phase changeALTO-203·Major depressive disorderPhase 2Phase 2 POC completed; missed single-dose primary efficacy endpoint amid high placebo response, but PD-positive and identified an EEG patient-selection biomarker.source ↗
- Jun 3, 2025Phase changeALTO-207·Treatment-resistant depressionPhase 2Alto Neuroscience acquired ALTO-207 (formerly CTC-501) from Chase Therapeutics; the completed Phase 2a study (NCT03642964) in MDD met primary and secondary endpoints (MADRS LSM diff vs placebo -8.2 at Week 8, p=0.025, Cohen's d=1.1).source ↗
- Feb 12, 2025Phase changeALTO-300 (agomelatine)·Major depressive disorderPhase 2Favorable Phase 2b interim analysis; study continues (final sample ~200); topline expected mid-2026.source ↗
- Oct 22, 2024Phase changeALTO-100 (amdiglurax)·Bipolar depressionPhase 2MDD Phase 2b (NCT05712187, n=301) did NOT meet its primary endpoint; MDD development halted.source ↗
- Oct 2, 2024Phase changeALTO-100 (amdiglurax)·Bipolar depressionPhase 2Phase 2b adjunctive bipolar-depression trial (NCT06656416) initiated.source ↗
- Jun 20, 2024Phase changeALTO-101·SchizophreniaPhase 2Phase 2 double-blind, placebo-controlled, dose-escalating crossover study of transdermal ALTO-101 in CIAS initiated (NCT06502964); primary endpoint = EEG theta band activity; ~70 adults (ages 21-55).source ↗
- Apr 11, 2024Phase changeALTO-203·Major depressive disorderPhase 2Phase 2 study of ALTO-203 in MDD with anhedonia initiated (NCT06391593).source ↗
- Jan 8, 2024Phase changeALTO-101·SchizophreniaPhase 1Positive Phase 1 results reported for ALTO-101, a novel PDE4 inhibitor; transdermal delivery showed substantially lower class-related (emetic) adverse events.source ↗
- Dec 4, 2023Phase changeALTO-300 (agomelatine)·Major depressive disorderPhase 2Positive MDD Phase 2a in EEG-biomarker-positive patients.source ↗
Trials recruiting · 3 recruiting of 13 sponsored
- Phase 2ALTO-207
A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
- Phase 2ALTO-100 (amdiglurax)
ALTO-100 Adjunctive in Bipolar Disorder With Depression
- Phase 2ALTO-300 (agomelatine)
Phase 2b Study of ALTO-300 (Agomelatine) in Major Depressive Disorder
Competitive landscape
Other companies developing against Alto Neuroscience, Inc.'s targets or indications.
- Intra-Cellular Therapies, Inc.1 compoundBipolar depressionSchizophreniaMajor depressive disorder
- LB Pharmaceuticals Inc.1 compoundBipolar depressionSchizophreniaMajor depressive disorder
- Taisho Pharmaceutical Co., Ltd.3 compoundsH3 receptorMajor depressive disorderTreatment-resistant depression
- Autobahn Therapeutics, Inc.1 compoundBipolar depressionMajor depressive disorder
- Beckley Psytech Limited2 compoundsMajor depressive disorderTreatment-resistant depression
- Boehringer Ingelheim International GmbH3 compoundsSchizophreniaMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.2 compoundsSchizophreniaMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorderTreatment-resistant depression
- GH Research PLC1 compoundBipolar depressionTreatment-resistant depression
- Merck & Co., Inc.2 compoundsSchizophreniaTreatment-resistant depression
- Neurocrine Biosciences, Inc.5 compoundsSchizophreniaMajor depressive disorder
- Vanda Pharmaceuticals Inc.2 compoundsSchizophreniaMajor depressive disorder
