Developer · United States

Sirtsei Pharmaceuticals, Inc.

Privately held US biopharmaceutical company and the registered sponsor of every clinical trial of forvisirvat (SP-624). Sirtsei holds the intellectual property for forvisirvat and is a subsidiary of Arrivo BioVentures, which states that it 'is the holding company for Sirtsei Pharmaceuticals, Inc. and Panafina Inc.' and which provides management oversight and funding and issues all public communications about the programme. Arrivo is based at 3000 RDU Center Drive, Morrisville, North Carolina, on the edge of Research Triangle Park, and has two clinical-stage assets: forvisirvat (SP-624) for major depressive disorder, held by Sirtsei, and RABI-767 for predicted severe acute pancreatitis, held by Panafina. No ticker: Arrivo and its subsidiaries are private.

arrivobio.com ↗

1compound
1program
1indication
Phase 2/3lead asset

Phase distribution

  • Phase 2/31

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Catalysts · 2 upcoming · 2 reported

  • July 2026Anticipated

    ForvisirvatforMajor depressive disorderRegistry results

    ClinicalTrials.gov estimated primary completion (and estimated study completion) of the confirmatory Phase 2b/3 study NCT06254612: 15 July 2026.

    NCT06254612source ↗

  • Later in 2026 (2H 2026)Anticipated

    ForvisirvatforMajor depressive disorderTopline data

    Topline results from the confirmatory Phase 2b/3 study SP-624-202 of forvisirvat 20 mg once daily vs placebo over 4 weeks in MDD (456 randomised; primary efficacy endpoint pre-specified in females), anticipated later in 2026.

    NCT06254612source ↗

Recently reported

  • 2025-01-10met

    ForvisirvatforMajor depressive disorderInterim analysis

    First cohort of the Phase 1 qEEG/Brain Network Analytics study SP-624-103 showed forvisirvat 20 mg once daily is centrally active in healthy adults: increased frontal-central beta power and decreased delta power versus placebo after single and 2-week dosing.

    source ↗

  • 2022-10-17missed

    ForvisirvatforMajor depressive disorderTopline data

    Phase 2 SP-624-201 in MDD missed its all-comers primary endpoint (MADRS change from baseline at Week 4: LS mean difference -1.8, p=0.133), but a post-hoc analysis of the 205 female participants showed a 3.9-point greater MADRS reduction than placebo at Week 4 (p=0.008), with no effect in males.

    source ↗

Recent activity

  • Jan 10, 2025ReadoutForvisirvat·Major depressive disordermetFirst cohort of the Phase 1 qEEG/Brain Network Analytics study SP-624-103 showed forvisirvat 20 mg once daily is centrally active in healthy adults: increased frontal-central beta power and decreased delta power versus placebo after single and 2-week dosing.source ↗
  • Mar 25, 2024Phase changeForvisirvat·Major depressive disorderPhase 2/3Confirmatory study SP-624-202 (NCT06254612) started per ClinicalTrials.gov actual start date; Arrivo announced initiation on 2024-04-16, describing it as a 'registration-quality Phase 2b study' of 450 subjects, and subsequently as a 'large Phase 2b/3 clinical trial' (2025-02-26) and 'a Phase 2b/3 study' (2026-05-21). CNS Pulse's own ASCP 2026 abstract likewise calls it a 'phase 2b-3 study'. The registry classifies it as PHASE2, so phase_2_3 here follows the sponsor's characterisation rather than the registry; the registry-fidelity alternative is phase_2. Status moved to ACTIVE, NOT RECRUITING by the 2026-05-15 registry update.source ↗
  • Oct 17, 2022ReadoutForvisirvat·Major depressive disordermissedPhase 2 SP-624-201 in MDD missed its all-comers primary endpoint (MADRS change from baseline at Week 4: LS mean difference -1.8, p=0.133), but a post-hoc analysis of the 205 female participants showed a 3.9-point greater MADRS reduction than placebo at Week 4 (p=0.008), with no effect in males.source ↗
  • Sep 30, 2020Phase changeForvisirvat·Major depressive disorderPhase 2Phase 2 study SP-624-201 (NCT04479852) started per ClinicalTrials.gov: multicentre, double-blind, randomised, placebo-controlled, 20 mg once daily vs placebo for 4 weeks in adults with MDD, primary endpoint change from baseline in MADRS total score at Week 4. Enrolment ultimately reached 319 patients at 39 US sites. Entry into Phase 2 was supported by the SP-624-101 (SAD) and SP-624-102 (MAD) Phase 1 studies in healthy adults, in which all doses exceeded the 3.28 ng/mL target plasma concentration and no serious adverse events occurred.source ↗

Competitive landscape

Other companies developing against Sirtsei Pharmaceuticals, Inc.'s targets or indications.