Developer · Switzerland
Hoffmann-La Roche
F. Hoffmann-La Roche Ltd is a Swiss healthcare company founded in Basel in 1896, operating through two divisions — Pharmaceuticals and Diagnostics — with neurology among its stated therapeutic priorities alongside oncology, cardiovascular and metabolic disease, ophthalmology, infectious disease and immunology. Its neuroscience portfolio has been a significant source of out-licensed clinical-stage psychiatry assets: the vasopressin V1a receptor antagonists balovaptan and NTX-1472 (RO6953958) both originated at Roche, the latter now in Phase 2 for social anxiety disorder at Newleos Therapeutics, whose pipeline was licensed from Roche.
Pipeline (1)
- Social anxiety disorderPhase 2Recruiting
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.
- 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).
Catalysts · 2 upcoming
- 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).
- 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.
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 ↗
- 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 ↗
Trials recruiting · 13 recruiting of 105 sponsored
- Phase 4Ocrelizumab
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
- Phase 3Prasinezumab, Placebo
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
- Phase 3Trontinemab
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
- Phase 3Trontinemab
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
- Phase 3Ocrelizumab
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
- Phase 2Ocrelizumab co-formulated with rHuPH20
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)
- Phase 2RO7268489, Ocrelizumab, Placebo
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)
- Phase 2Ocrelizumab Test Formulation, Ocrelizumab Reference Formulation
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
- Phase 2Fenebrutinib
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
- Phase 1RO7812653, Placebo
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
- Phase 1RG6496, Placebo
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease
- Phase 1RO7121932 IV, RO7121932 SC
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Showing 12 of 13 recruiting trials.
Competitive landscape
Other companies developing against Hoffmann-La Roche's targets or indications.