Developer · SNY · France

Sanofi

Sanofi is a French multinational biopharmaceutical company that describes itself as an R&D-driven, AI-powered biopharma. It concentrates on five therapeutic areas — immunology, neurology, oncology, rare diseases and vaccines — with 77 compounds in clinical development and 28 trials in Phase 3. Its historical psychiatry research produced the arginine-vasopressin V1B receptor antagonist nelivaptan (SSR149415), the first selective nonpeptide V1B antagonist described, now being redeveloped as BH-200 for major depressive disorder.

sanofi.com ↗

1compound
1program
1indication
Phase 2lead asset

Phase distribution

  • Phase 21

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

  • Jun 15, 2026FinancingHMNC closes first $50M tranche of a Series B; proceeds fund BH-200 Phase 3 readinessHMNC Brain Health announced a $50 million first closing of its Series B, led by MEDICE - The Health Family with participation from existing investor The Maschmeyer Group. Proceeds support late-stage clinical development of the neuroscience portfolio, including Phase 3-readiness activities for Ketabon (KET01) and Nelivabon (BH-200). The same announcement covered a strategic partnership granting MEDICE exclusive European commercialisation rights to KET01 with tiered double-digit royalties and success-based commercial milestones, and noted HMNC is evaluating expansion of the BH-200 programme into additional neuroscience indications.Nelivaptan (BH-200)source ↗
  • Sep 16, 2021Licensing dealHMNC Brain Health in-licenses BH-200 (nelivaptan) worldwide and exclusively from SanofiHMNC Brain Health announced worldwide exclusive rights to BH-200, the vasopressin V1b receptor antagonist nelivaptan (Sanofi's SSR149415), in-licensed from Sanofi and paired with a proprietary molecular diagnostic that identifies patients whose major depressive disorder is driven by HPA-axis dysfunction. HMNC's stated rationale was that BH-200 had met the predefined primary endpoint in one of Sanofi's two MDD studies despite being tested in an unselected population. A two-study Phase 2 programme operated by ICON was announced with first patient targeted for Q1 2022 and first results for Q2 2023.Nelivaptan (BH-200)source ↗

Catalysts · 0 upcoming · 1 reported

Recently reported

  • 2025-08-05mixed

    Nelivaptan (BH-200)forMajor depressive disorderTopline data

    OLIVE (BH-200-03) Phase 2b topline in MDD: the prespecified primary endpoint — HAM-D17 change to Week 8 in genetic Subgroup C — was MISSED (-1.94, p=0.153), while the full mITT population (N=331) separated (-2.98, p=0.0003) and the best-performing genetic subgroup A (n=89) reached -4.47 (p=0.005) with separation from Week 1.

    source ↗

Recent activity

  • Aug 5, 2025ReadoutNelivaptan (BH-200)·Major depressive disordermixedOLIVE (BH-200-03) Phase 2b topline in MDD: the prespecified primary endpoint — HAM-D17 change to Week 8 in genetic Subgroup C — was MISSED (-1.94, p=0.153), while the full mITT population (N=331) separated (-2.98, p=0.0003) and the best-performing genetic subgroup A (n=89) reached -4.47 (p=0.005) with separation from Week 1.source ↗
  • May 1, 2023Phase changeNelivaptan (BH-200)·Major depressive disorderPhase 2OLIVE (BH-200-03, EudraCT 2022-002757-26) begins enrolling. German competent-authority (BfArM) decision 2023-03-28, favourable ethics opinion 2023-04-26; HMNC states enrolment ran May 2023 to April 2025 across eight European countries, later extended to Serbia under CTIS 2024-513104-34-00 (authorised 2024-09-24). Month precision on the start; the day is an anchor.source ↗
  • Sep 16, 2021Phase changeNelivaptan (BH-200)·Major depressive disorderPhase 2Programme revived: HMNC Brain Health announces it has in-licensed BH-200 (nelivaptan) worldwide on an exclusive basis from Sanofi, pairing it with a molecular diagnostic that identifies HPA-axis-driven MDD. HMNC's stated rationale is that BH-200 'met the predefined primary endpoint in one of the two MDD studies conducted' at Sanofi despite being tested in an unselected population. A two-study Phase 2 programme operated by ICON was announced, with first patient targeted for Q1 2022 and first results for Q2 2023 — both of which slipped (OLIVE actually enrolled May 2023 to April 2025).source ↗
  • Jul 1, 2008Phase changeNelivaptan (BH-200)·Major depressive disorderPhase 2Sanofi halts development of SSR149415. NCATS Inxight Drugs states 'In 2008, Sanofi-Aventis announced that further development of this drug had been halted' — YEAR precision only; 2008-07-01 is a sortable anchor within 2008 and must not be read as day-precise (status_history has no precision column). Basis: the Phase 2 programme did not demonstrate clear efficacy in unselected patients. Per a 2021 Int J Neuropsychopharmacol review, in DFI5878 SSR149415 250 mg (but not 100 mg) gave significantly greater HDRS reduction than placebo, but the trial failed assay sensitivity because the escitalopram active control also failed to separate; in DFI5879 neither dose separated while the paroxetine control did; and in GAD neither dose improved primary or secondary anxiety measures. All four registry records show status Completed, so this is a sponsor portfolio decision, not a trial termination.source ↗
  • Jul 1, 2006Phase changeNelivaptan (BH-200)·Major depressive disorderPhase 2Sanofi (then Sanofi-Aventis) enters Phase 2 in MDD with SSR149415: DFI5878 (NCT00358631), an 8-week study of two doses in 319 US outpatients with major depressive disorder, start date recorded on ClinicalTrials.gov as July 2006 (month precision — the day is an anchor, not a registry fact). Three further Phase 2 studies followed within two months: DFI5879 (NCT00361491, MDD, 324 patients, August 2006), PDY5467 (NCT01606384, HPA-axis effects in MDD, 100 patients, December 2006) and DFI5880 (NCT00374166, GAD, 325 patients, August 2006).source ↗

Trials recruiting · 1 recruiting of 122 sponsored

  • Phase 3Frexalimab, MRI contrast-enhancing preparationsn=16034 sites · United States, Belgium, China

    Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

    Multiple SclerosisNCT07325292 ↗

Competitive landscape

Other companies developing against Sanofi's targets or indications.