Developer · NVS · Switzerland

Novartis Pharma AG

Global pharmaceutical company headquartered in Basel, Switzerland (NYSE: NVS, SIX: NOVN). Originated mavoglurant (AFQ056) and ran its fragile X, levodopa-induced-dyskinesia, Huntington's, OCD and cocaine-use-disorder programs before out-licensing the compound worldwide to Stalicla SA in January 2023.

novartis.com ↗

1compound
4programs
4indications
Phase 2lead asset

Phase distribution

  • Phase 21
  • Discontinued3

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

  • Jan 9, 2023Licensing dealStalicla in-licenses worldwide rights to mavoglurant (AFQ056 → STP7) from NovartisStalicla SA signed an exclusive in-licensing agreement with Novartis for mavoglurant, covering substance-use disorder and neurodevelopmental-disorder indications worldwide: upfront fees plus an equity stake to Novartis, up to $270 million in development and commercial milestones, plus royalties. Stalicla announced it was preparing to advance mavoglurant into Phase 3 for cocaine use disorder on the back of Novartis's positive Phase 2 (NCT03242928) and a >1,800-adult legacy safety database.Mavoglurantsource ↗

Catalysts · 0 upcoming · 1 reported

Recently reported

  • 2025-04-02met

    MavoglurantforCocaine use disorderFull results

    Phase 2 full results published in Science Translational Medicine: mavoglurant reduced cocaine use versus placebo in 68 adults with cocaine use disorder (NCT03242928), the evidence base for Stalicla's planned Phase 3.

    source ↗

Recent activity

  • Apr 2, 2025ReadoutMavoglurant·Cocaine use disordermetPhase 2 full results published in Science Translational Medicine: mavoglurant reduced cocaine use versus placebo in 68 adults with cocaine use disorder (NCT03242928), the evidence base for Stalicla's planned Phase 3.source ↗
  • Jan 9, 2023Phase changeMavoglurant·Cocaine use disorderPhase 2Program changed hands: Stalicla SA in-licensed worldwide rights to mavoglurant from Novartis for substance-use and neurodevelopmental disorders and announced preparation to advance it into Phase 3 for cocaine use disorder. Phase unchanged — the Phase 3-enabling package (DDI study) was still outstanding.source ↗
  • Dec 16, 2019Phase changeMavoglurant·Cocaine use disorderPhase 2Phase 2 NCT03242928 completed (primary completion and study completion 2019-12-16). Results — reduced cocaine use versus placebo — were later published in Science Translational Medicine (2025-04-02).source ↗
  • Dec 4, 2017Phase changeMavoglurant·Cocaine use disorderPhase 2Novartis Phase 2 NCT03242928 (CAFQ056X2201) started: randomized, blinded, placebo-controlled study of whether AFQ056 reduces cocaine use in adults with cocaine use disorder (n=68 actual).source ↗
  • Nov 1, 2014Phase changeMavoglurant·Obsessive-compulsive disorderDiscontinuedRegistry whyStopped: 'Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective.' CT.gov completion month November 2014 (month precision; day is an anchor). The 2017 publication confirmed lack of efficacy over placebo, and no sponsor has developed mavoglurant in OCD since.source ↗
  • Apr 24, 2014Phase changeMavoglurant·Fragile X syndromeDiscontinuedNovartis announced it would discontinue mavoglurant development in fragile X after both Phase 2b studies (CAFQ056A2212 adults; CAFQ056B2214 adolescents) failed to meet primary endpoints — no significant improvement in abnormal behaviors versus placebo in adults or adolescents, in any methylation stratum. The open-label extensions were subsequently terminated (September 2014); NCT01348087's registry reason: 'Study treatment AFQ056 failed to demonstrate efficacy in the adult patient'; NCT01433354's: 'The study treatment failed to demonstrate efficacy in target population'. The later academic FXLEARN study (completed 2022; JCI 2023) was independent of Novartis's decision and also negative.source ↗
  • Nov 1, 2013Phase changeMavoglurant·Obsessive-compulsive disorderPhase 2Phase 2 proof-of-concept NCT01813019 started (CT.gov month precision: November 2013): AFQ056 vs placebo augmentation in OCD patients resistant to SSRI treatment.source ↗
  • Aug 1, 2011Phase changeMavoglurant·Huntington's diseaseDiscontinuedTrial registered TERMINATED with primary completion August 2011 (month precision; no whyStopped text on the registry). The published result (Reilmann et al., Mov Disord 2015) reported no significant anti-choreatic effect versus placebo despite acceptable safety/tolerability. Discontinuation date is INFERRED from trial cessation plus the absence of any later HD activity — Novartis never issued an HD-specific discontinuation announcement; press coverage of the 2023 Stalicla deal notes Novartis had discontinued mavoglurant development across all indications.source ↗
  • Nov 1, 2010Phase changeMavoglurant·Fragile X syndromePhase 2Confirmatory Phase 2b program began: double-blind dose-ranging study in adults (NCT01253629, 25/50/100 mg bid vs placebo, n=175, stratified by FMR1 methylation), followed by the adolescent study NCT01357239 (May 2011, n=139) and open-label extensions NCT01348087 (adults) and NCT01433354 (adolescents; registered Phase 2/3). CT.gov gives month precision.source ↗
  • Nov 1, 2009Phase changeMavoglurant·Huntington's diseasePhase 2Phase 2 proof-of-concept NCT01019473 started (CT.gov month precision: November 2009): randomized, double-blind, placebo-controlled, multiple oral dose titration of AFQ056 in patients with Huntington's disease, targeting reduction of chorea.source ↗
  • Jun 1, 2008Phase changeMavoglurant·Fragile X syndromePhase 2Exploratory Phase 2 crossover study NCT00718341 started (n=30 adult males with FXS). Post-hoc analysis suggested behavioral improvement confined to the subgroup with fully methylated FMR1 promoters — the stratification hypothesis the Phase 2b program was built to confirm. CT.gov gives month precision (June 2008); day is an anchor.source ↗

Trials recruiting · 10 recruiting of 228 sponsored

  • Phase 4Fingolimodn=306 sites · Taiwan

    Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis

    Multiple SclerosisNCT04480853 ↗

  • Phase 3Placebon=30024 sites · Germany, Spain, United States

    A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy

    Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)NCT07498426 ↗

  • Phase 3Votoplam (blinded), Placebon=77027 sites · United States, United Kingdom, Canada

    A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease

    Huntington DiseaseNCT07326709 ↗

  • Phase 3Remibrutinib (blinded), Placebo, Remibrutinib (Open label)n=1275223 sites · United States, France, China

    A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

    Secondary Progressive Multiple Sclerosis (SPMS)NCT07225504 ↗

  • Phase 3Remibrutinib oral treatment, Ocrelizumabn=360106 sites · United States, France, Spain

    Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

    Relapsing Multiple SclerosisNCT06846281 ↗

  • Phase 2GXV813, Placebon=1427 sites · United States

    Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

    SchizophreniaNCT07467993 ↗

Showing 6 of 10 recruiting trials.

Competitive landscape

Other companies developing against Novartis Pharma AG's targets or indications.