Developer · ROG · Switzerland

F. Hoffmann-La Roche Ltd

Global healthcare company headquartered in Basel, Switzerland (SIX: ROG), with pharmaceutical and diagnostics divisions. In psychiatry it developed and discontinued the V1a antagonist balovaptan (autism, PTSD) and the TAAR1 partial agonist ralmitaront.

roche.com ↗

4compounds
5programs
5indications
Phase 2lead asset

Phase distribution

  • Phase 21
  • Discontinued4

Modality

  • Small molecule 3
  • Biologic 1

Mechanism focus

Pipeline (4)

Deals & partnerships

  • NTX-1472Led by Newleos Therapeutics, Inc.
  • Feb 13, 2025Licensing dealNewleos Therapeutics licenses ralmitaront from Roche as NTX-2001Newleos Therapeutics launched with $93M (Longwood Fund) and a four-asset CNS portfolio licensed from Roche, including ralmitaront — renamed NTX-2001 — which Roche had removed from its pipeline in October 2023. Newleos plans to develop NTX-2001 in alcohol use disorder, not schizophrenia; deal structure was upfront + milestones + royalties, amounts undisclosed. Recorded compound-wide (no indication) so this schizophrenia record does not claim the new indication; the AUD program is a separate record when written.Ralmitarontsource ↗
  • Feb 13, 2025FinancingNewleos Therapeutics launches with an oversubscribed $93.5 million Series ANewleos Therapeutics debuted publicly with a $93.5 million oversubscribed Series A financing led by Goldman Sachs Alternatives, with participation from Novo Holdings A/S, Longwood Fund, DCVC Bio and Arkin Bio Capital. The proceeds fund the four ex-Roche clinical-stage programmes, of which NTX-1472 in social anxiety disorder is the most advanced.NTX-1472source ↗
  • Feb 13, 2025Licensing dealNewleos in-licenses NTX-1472 (RO6953958) and three other clinical-stage neuropsychiatry assets from RocheAt its public launch, Newleos Therapeutics disclosed that it had licensed global rights to four clinical-stage neuropsychiatric assets from Roche in exchange for an upfront payment plus success-based milestones and royalties. The portfolio comprises NTX-1955 (GABAA-gamma1 positive allosteric modulator, generalized anxiety disorder), NTX-1472 (RO6953958, V1a receptor antagonist, social anxiety disorder), NTX-2001 (ralmitaront, TAAR1 partial agonist, substance use disorders) and NTX-1511 (basmisanil, GABAA-alpha5 negative allosteric modulator, cognitive impairment in rare neurodevelopmental disease).NTX-1472source ↗

Catalysts · 2 upcoming · 8 reported

  • January 2027Anticipated

    NTX-1472forSocial anxiety disorderRegistry results

    ClinicalTrials.gov estimated primary completion of the SOAR Phase 2 study (NCT07323784): January 2027 (estimated study completion also January 2027).

    NCT07323784source ↗

  • 1H 2027Anticipated

    NTX-1472forSocial anxiety disorderTopline data

    Topline data from the Phase 2 SOAR proof-of-concept study of NTX-1472 210 mg once daily versus placebo in generalized social anxiety disorder — safety/tolerability primary, LSAS the key efficacy secondary — expected 1H 2027.

    NCT07323784source ↗

Recently reported

  • 2025-03-19mixed

    GantenerumabforAlzheimer's diseaseFull results

    DIAN-TU gantenerumab open-label extension (Lancet Neurology): amyloid PET fell profoundly (PiB-PET SUVR -0.71, p<0.0001); symptom-onset/progression risk halved in the longest-treated asymptomatic carriers (HR 0.53, 95% CI 0.27-1.03) but not overall (HR 0.79, 0.47-1.32); combined ARIA 53%, symptomatic ARIA-E 6%, no deaths.

    source ↗

  • 2024-11-11missed

    BalovaptanforPost-traumatic stress disorderFull results

    EXUVIA Phase 2 in adult PTSD: balovaptan 10 mg did not separate from placebo on CAPS-5 total severity at week 12 (-17.2 vs -15.6) or on any secondary endpoint.

    source ↗

  • 2023-10-10missed

    RalmitarontforSchizophreniaFull results

    Acute-exacerbation Phase 2 failed: neither ralmitaront 45 mg (+0.60 vs placebo, p=0.849) nor 150 mg (-2.83, p=0.362) separated on Week-4 PANSS total, while the risperidone 4 mg active control did (-10.45, p=0.001).

    source ↗

  • 2023-05-23missed

    RalmitarontforSchizophreniaInterim analysis

    Negative-symptoms Phase 2 terminated after an interim analysis indicated ralmitaront was unlikely to meet its BNSS primary endpoint at Week 12.

    source ↗

  • 2022-11-14missed

    GantenerumabforAlzheimer's diseaseTopline data

    GRADUATE II failed: CDR-SB difference -0.19 vs placebo at week 116 (6% relative slowing, p=0.2998).

    source ↗

  • 2022-11-14missed

    GantenerumabforAlzheimer's diseaseTopline data

    GRADUATE I failed: CDR-SB difference -0.31 vs placebo at week 116 (8% relative slowing, p=0.0954); amyloid removal lower than expected; ARIA-E 25%.

    source ↗

  • 2022-08-01missed

    BalovaptanforAutism spectrum disorderFull results

    aV1ation Phase 2 (339 children and adolescents 5-17 with ASD, 24 weeks): no difference vs placebo on Vineland-II 2DC (LS-mean difference -0.16; 90% CI -2.56 to 2.23; P=.91) or any secondary endpoint.

    source ↗

  • 2022-02-10missed

    BalovaptanforAutism spectrum disorderFull results

    V1aduct Phase 3 (322 autistic adults, balovaptan 10 mg vs placebo, 24 weeks): terminated for futility; no improvement on Vineland-II 2DC (interim LS-mean change 2.91 vs 4.75 placebo; difference -1.84, 95% CI -5.15 to 1.48).

    source ↗

Recent activity

  • Dec 9, 2025Phase changeNTX-1472·Social anxiety disorderPhase 2SOAR (NCT07323784) actual study start per ClinicalTrials.gov. The record was first posted 2026-01-07 and last updated 2026-07-09, with overall status RECRUITING; 10 of the 11 US sites are recruiting and the Las Vegas site is active-not-recruiting. Newleos announced the first participant dosed on 2026-01-06.source ↗
  • Oct 1, 2025Phase changeNTX-1472·Social anxiety disorderPhase 2Entry into Phase 2 for social anxiety disorder. Newleos announced on 2025-10-01 that the FDA had cleared its Investigational New Drug application to begin the Phase 2 SOAR study of NTX-1472 in SAD in the United States. The study had not yet initiated at that date. This is the compound's first regulatory step in an anxiety indication under Newleos and the basis for last_phase_change. NOTE: there is no closed-vocabulary event code for an IND clearance, so this milestone is carried in the status history rather than as an events[] row.source ↗
  • Mar 19, 2025ReadoutGantenerumab·Alzheimer's diseasemixedDIAN-TU gantenerumab open-label extension (Lancet Neurology): amyloid PET fell profoundly (PiB-PET SUVR -0.71, p<0.0001); symptom-onset/progression risk halved in the longest-treated asymptomatic carriers (HR 0.53, 95% CI 0.27-1.03) but not overall (HR 0.79, 0.47-1.32); combined ARIA 53%, symptomatic ARIA-E 6%, no deaths.source ↗
  • Nov 11, 2024ReadoutBalovaptan·Post-traumatic stress disordermissedEXUVIA Phase 2 in adult PTSD: balovaptan 10 mg did not separate from placebo on CAPS-5 total severity at week 12 (-17.2 vs -15.6) or on any secondary endpoint.source ↗
  • Oct 19, 2023Phase changeRalmitaront·SchizophreniaDiscontinuedRoche removed ralmitaront from its development pipeline at the Q3 2023 investor update (Basel, 19 October 2023): the presentation appendix lists 'Removed from phase II — RG7906 ralmitaront – schizophrenia'. This followed the May 2023 termination of the negative-symptoms study (negative interim analysis) and the earlier negative acute-exacerbation readout. No event code exists for a program discontinuation, so this row is the canonical record of it.source ↗
  • Oct 10, 2023ReadoutRalmitaront·SchizophreniamissedAcute-exacerbation Phase 2 failed: neither ralmitaront 45 mg (+0.60 vs placebo, p=0.849) nor 150 mg (-2.83, p=0.362) separated on Week-4 PANSS total, while the risperidone 4 mg active control did (-10.45, p=0.001).source ↗
  • Oct 5, 2023Phase changeBalovaptan·Post-traumatic stress disorderPhase 2EXUVIA completed (actual primary completion and study completion 2023-10-05); 29 randomised.source ↗
  • May 23, 2023ReadoutRalmitaront·SchizophreniamissedNegative-symptoms Phase 2 terminated after an interim analysis indicated ralmitaront was unlikely to meet its BNSS primary endpoint at Week 12.source ↗
  • Nov 30, 2022Phase changeGantenerumab·Alzheimer's diseaseDiscontinuedAt CTAD (San Francisco) Roche presented the full GRADUATE data and announced discontinuation of gantenerumab development: the GRADUATION once-weekly-dosing Phase 2, the PostGraduate open-label extension, OpenRoAD, and the SKYLINE secondary-prevention Phase 3 were all halted. ClinicalTrials.gov records the terminations with whyStopped 'Decision to terminate development of Gantenerumab ... following results of a pre-planned analysis of the safety and efficacy of Gant in Grad[uate]' (SKYLINE terminated 2023-03-13; GRADUATION completed termination 2023-03-15; PostGraduate 2023-03-06). The only study allowed to continue was the investigator-led DIAN-TU open-label extension, whose dosing the sponsor stopped in August 2023 for lack of a regulatory path. No event code exists for a program discontinuation, so this row is the canonical record of it.source ↗
  • Nov 14, 2022ReadoutGantenerumab·Alzheimer's diseasemissedGRADUATE II failed: CDR-SB difference -0.19 vs placebo at week 116 (6% relative slowing, p=0.2998).source ↗
  • Nov 14, 2022ReadoutGantenerumab·Alzheimer's diseasemissedGRADUATE I failed: CDR-SB difference -0.31 vs placebo at week 116 (8% relative slowing, p=0.0954); amyloid removal lower than expected; ARIA-E 25%.source ↗
  • Aug 2, 2022Phase changeBalovaptan·Post-traumatic stress disorderPhase 2EXUVIA Phase 2 in adult PTSD started (registry actual start 2022-08-02).source ↗

Trials recruiting · 13 recruiting of 105 sponsored

  • Phase 4Ocrelizumabn=6017 sites · China

    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

    Relapsing Multiple SclerosisPrimary Progressive Multiple SclerosisNCT07483450 ↗

  • Phase 3Prasinezumab, Placebon=900160 sites · United States, China, Germany

    A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

    Parkinson's DiseaseNCT07174310 ↗

  • Phase 3Trontinemabn=800150 sites · United States, Germany, South Korea

    A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

    Alzheimers DiseaseNCT07170150 ↗

  • Phase 3Trontinemabn=800143 sites · United States, China, Germany

    A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

    Alzheimers DiseaseNCT07169578 ↗

  • Phase 3Ocrelizumabn=50044 sites · Russia, Ukraine, France

    An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

    Multiple SclerosisNCT06675955 ↗

  • Phase 2Ocrelizumab co-formulated with rHuPH20n=25

    A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

    Relapsing-remitting Multiple SclerosisNCT07503340 ↗

  • Phase 2RO7268489, Ocrelizumab, Placebon=36091 sites · Spain, Poland, France

    A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)

    Progressive Multiple SclerosisNCT07282574 ↗

  • Phase 2Ocrelizumab Test Formulation, Ocrelizumab Reference Formulationn=18256 sites · United States, Spain, Brazil

    A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

    Multiple SclerosisNCT07074886 ↗

  • Phase 2Fenebrutinibn=1217 sites · Brazil, Poland, Spain

    A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)

    Relapsing Multiple SclerosisNCT07161258 ↗

  • Phase 1RO7812653, Placebon=508 sites · United Kingdom, Sweden, Netherlands

    A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)

    Alzheimer's DiseaseNCT07234942 ↗

  • Phase 1RG6496, Placebon=404 sites · Australia, New Zealand, Argentina

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease

    Huntington's DiseaseNCT07246941 ↗

  • Phase 1RO7121932 IV, RO7121932 SCn=12932 sites · Poland, Germany, United States

    A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis

    Multiple SclerosisNCT05704361 ↗

Showing 12 of 13 recruiting trials.

Competitive landscape

Other companies developing against F. Hoffmann-La Roche Ltd's targets or indications.