Developer · ROG · Switzerland

F. Hoffmann-La Roche Ltd

Global healthcare company headquartered in Basel, Switzerland (SIX: ROG), with pharmaceutical and diagnostics divisions. Its neuroscience pipeline spans multiple sclerosis, spinal muscular atrophy, Alzheimer's disease and neuromuscular disease. In Alzheimer's disease Roche developed and discontinued the anti-amyloid antibody gantenerumab (2022) and the anti-tau antibody semorinemab, and is advancing the Brainshuttle-enabled anti-amyloid antibody trontinemab; in psychiatry it discontinued the TAAR1 partial agonist ralmitaront (2023) and has out-licensed several CNS assets.

roche.com ↗

3compounds
3programs
3indications
Phase 2lead asset

Phase distribution

  • Phase 21
  • Discontinued2

Modality

  • Small molecule 2
  • Biologic 1

Mechanism focus

Pipeline (3)

Deals & partnerships

  • NTX-1472Led by Newleos Therapeutics, Inc.
  • 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 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, 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 · 7 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 ↗

  • 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 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 ↗

  • 2022-11-14missed

    GantenerumabforAlzheimer's diseaseTopline data

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

    source ↗

  • 2020-02-10missed

    GantenerumabforAlzheimer's diseaseTopline data

    DIAN-TU-001 gantenerumab arm missed its cognitive primary endpoint in dominantly inherited Alzheimer's disease; amyloid, tau and neurofilament biomarkers moved in the desired direction.

    source ↗

  • 2014-12-19missed

    GantenerumabforAlzheimer's diseaseInterim analysis

    SCarlet RoAD dosing halted for futility: gantenerumab 105/225 mg q4w was unlikely to meet its CDR-SB primary endpoint in prodromal Alzheimer's disease.

    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 ↗
  • 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 ↗
  • 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 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 ↗
  • 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 ↗
  • Jun 21, 2022Phase changeRalmitaront·SchizophreniaPhase 2The acute-exacerbation study NCT04512066 reached actual completion. Roche issued no press release; results posted to the registry on 2023-10-10 show both ralmitaront doses failed to separate from placebo on Week-4 PANSS total while risperidone separated. After this date only the negative-symptoms study remained active.source ↗
  • Feb 6, 2022Phase changeNTX-1472·Social anxiety disorderPhase 1Phase 1 package completed under Roche. Study BP41695 (NCT04475848), a randomized, investigator/subject-blind, placebo-controlled single- and multiple-ascending-dose, food-effect and midazolam-DDI study in 88 healthy male participants at Hammersmith Medicines Research, London, ran 2020-07-15 to 2022-02-06 (actual primary completion and actual completion the same date; results posted on ClinicalTrials.gov 2024-07-10). REGISTRY-FIDELITY CAVEAT: Roche registered this study under autism-spectrum conditions, not social anxiety disorder — it sat inside Roche's autism franchise as the follow-on to balovaptan. It is recorded here because it is the Phase 1 package that Newleos's SAD Phase 2 dose selection rests on, but it is deliberately NOT loaded into trials[] (the loader would re-attribute its sponsor to Newleos and its indication to SAD). A second, open-label 2-period itraconazole drug-drug-interaction study in 16 participants was also completed under Roche; it is not registered on ClinicalTrials.gov under either of the two study codes the sponsor has published for it.source ↗
  • Sep 8, 2020Phase changeRalmitaront·SchizophreniaPhase 2Second Phase 2 study started: NCT04512066 (BP41743), monotherapy in acute exacerbation of schizophrenia or schizoaffective disorder — 45 mg and 150 mg QD vs placebo with a risperidone 4 mg active control; primary endpoint change from baseline in PANSS total at Week 4; 287 enrolled.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.