Developer · Japan
Taisho Pharmaceutical Co., Ltd.
Taisho Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, known for consumer self-medication products (e.g. Lipovitan) and a prescription drug business with CNS programs in insomnia, depression and narcolepsy. It is the principal operating subsidiary of Taisho Pharmaceutical Holdings Co., Ltd., which was taken private by the founding Uehara family in an April 2024 management buyout and delisted from the Tokyo Stock Exchange.
Phase distribution
Modality
- Small molecule 4
Mechanism focus
Pipeline (4)
- InsomniaApprovedApproved
- Major depressive disorderDiscontinuedDiscontinued
- NarcolepsyDiscontinuedDiscontinued
- Treatment-resistant depressionDiscontinuedDiscontinued
Deals & partnerships
- Brezivaptan (TS-121 / ANC-501)Led by OOTEMON Co., Ltd.Licensee Ancora Bio, Inc.Partner Aditum Bio
- Enerisant (TS-091)Led by OOTEMON Co., Ltd.
- TS-161Led by OOTEMON Co., Ltd.
- Vornorexant (TS-142)Led by OOTEMON Co., Ltd.Partner Meiji Seika Pharma Co., Ltd.
- Feb 6, 2025PartnershipTaisho and Meiji Seika Pharma to co-market vornorexant (TS-142) for insomnia in JapanTaisho announced on Feb 6, 2025 a joint-marketing agreement with Meiji Seika Pharma Co., Ltd. to co-promote its in-house dual orexin receptor antagonist vornorexant (TS-142) for insomnia in Japan. The agreement was struck while the product was under Japanese regulatory review; vornorexant was subsequently approved in Japan (marketed as Vorzzz). Taisho retains the development/marketing-authorization lead.
- Apr 9, 2024AcquisitionTaisho Pharmaceutical Holdings taken private in Uehara-family management buyout (OOTEMON)The founding Uehara family executed a management buyout of Taisho Pharmaceutical Holdings Co., Ltd. (parent of Taisho Pharmaceutical Co., Ltd.) through the acquisition vehicle OOTEMON Co., Ltd. Following a tender offer at JPY 8,620 per share (announced Nov 24, 2023; tender expired Jan 15, 2024 with ~73% accepted) and a March 2024 EGM-approved share consolidation/squeeze-out, the company was delisted from the Standard Market of the Tokyo Stock Exchange effective April 9, 2024, in a deal valued at roughly USD 5 billion.
- Jun 30, 2021Licensing dealTaisho out-licenses V1b antagonist TS-121 (brezivaptan / ANC-501) to Ancora Bio worldwideTaisho granted Ancora Bio, Inc. (an Aditum Bio spinout) an exclusive worldwide license for the development, manufacturing and commercialization of its selective vasopressin V1b receptor antagonist TS-121 (renamed ANC-501; later named brezivaptan) for depression, including treatment-resistant depression. Terms: an undisclosed upfront payment plus development milestones, commercial (net-sales) milestones and running royalties to Taisho; Ancora assumes development lead.
Catalysts · 1 upcoming · 5 reported
- 2025-06-10Anticipated
TS-161forTreatment-resistant depressionFull results
Recently reported
- 2025-08-25met
Vornorexant (TS-142)forInsomniaRegulatory
Japan MHLW approved Vorzzz (vornorexant hydrate) 2.5/5/10 mg for insomnia.
- 2025-06-28met
Vornorexant (TS-142)forInsomniaFull results
Pivotal Phase 3 TS142-301 met primary (sSL) and key secondary (sSE) endpoints at both 5 mg and 10 mg (p<0.001).
- 2023-10-18met
Brezivaptan (TS-121 / ANC-501)forMajor depressive disorderTopline data
EmbarkNeuro open-label Phase 2 (NCT05439603, n=15) completed: mean MADRS reduction ~17.5 pts at 8 wk (single-arm, no placebo).
- 2022-02-22missed
Enerisant (TS-091)forNarcolepsyFull results
Both Phase 2 fixed-dose trials of enerisant (TS-091) in narcolepsy missed the primary MWT endpoint; the optimal dose could not be determined (efficacy on ESS only at poorly tolerated 25-50 mg doses, while well-tolerated 5-10 mg doses lacked efficacy).
- 2020-06-01missed
Brezivaptan (TS-121 / ANC-501)forMajor depressive disorderFull results
Taisho Phase 2 (NCT03093025) missed primary: MADRS 10mg/50mg -9.0 vs placebo -6.4, no significant separation; trial terminated (sponsor decision).
Recent activity
- Aug 25, 2025ReadoutVornorexant (TS-142)·InsomniametJapan MHLW approved Vorzzz (vornorexant hydrate) 2.5/5/10 mg for insomnia.source ↗
- Jun 28, 2025ReadoutVornorexant (TS-142)·InsomniametPivotal Phase 3 TS142-301 met primary (sSL) and key secondary (sSE) endpoints at both 5 mg and 10 mg (p<0.001).source ↗
- Sep 12, 2024Phase changeVornorexant (TS-142)·InsomniaFiled (NDA)Taisho submitted the Japanese manufacturing and marketing approval application (J-NDA) for vornorexant hydrate for insomnia.source ↗
- May 23, 2024Phase changeTS-161·Treatment-resistant depressionDiscontinuedPhase 2 trial NCT04821271 terminated due to low recruitment (11 actual enrollment); primary completion 2024-05-23. Results posted 2025-06-10 showed no separation from placebo on MADRS at day 21 (p=0.91, zero remitters) - a negative efficacy readout.source ↗
- Dec 5, 2023Phase changeVornorexant (TS-142)·InsomniaPhase 3TS142-301 completed; primary endpoint (subjective sleep latency, Week 2) and key secondary (subjective sleep efficiency) met at both doses (p<0.001).source ↗
- Oct 18, 2023ReadoutBrezivaptan (TS-121 / ANC-501)·Major depressive disordermetEmbarkNeuro open-label Phase 2 (NCT05439603, n=15) completed: mean MADRS reduction ~17.5 pts at 8 wk (single-arm, no placebo).source ↗
- Nov 21, 2022Phase changeBrezivaptan (TS-121 / ANC-501)·Major depressive disorderPhase 2Asset relaunched: Ancora Bio (d/b/a EmbarkNeuro), formed by Aditum Bio, in-licensed the compound from Taisho and dosed the first patient in a new open-label, single-arm, cortisol-enriched Phase 2 trial of ANC-501 (50 mg/day x 8 weeks) for MDD (NCT05439603).source ↗
- Aug 30, 2022Phase changeVornorexant (TS-142)·InsomniaPhase 3Pivotal Phase 3 study TS142-301 (NCT05453136 / jRCT2031220209) initiated in Japanese insomnia patients (5 mg / 10 mg / placebo, 2-week double-blind).source ↗
- Feb 22, 2022ReadoutEnerisant (TS-091)·NarcolepsymissedBoth Phase 2 fixed-dose trials of enerisant (TS-091) in narcolepsy missed the primary MWT endpoint; the optimal dose could not be determined (efficacy on ESS only at poorly tolerated 25-50 mg doses, while well-tolerated 5-10 mg doses lacked efficacy).source ↗
- Jun 10, 2021Phase changeTS-161·Treatment-resistant depressionPhase 2Phase 2 proof-of-concept crossover study in treatment-resistant depression (NCT04821271, lead sponsor NIMH, collaborator Taisho) started June 10, 2021.source ↗
- Jun 1, 2020ReadoutBrezivaptan (TS-121 / ANC-501)·Major depressive disordermissedTaisho Phase 2 (NCT03093025) missed primary: MADRS 10mg/50mg -9.0 vs placebo -6.4, no significant separation; trial terminated (sponsor decision).source ↗
- Feb 11, 2020Phase changeTS-161·Treatment-resistant depressionPhase 1First-in-human Phase 1 single/multiple ascending dose study in healthy participants (NCT03919409, sponsor Taisho Pharmaceutical R&D Inc., 70 participants) completed; primary completion Feb 11, 2020. Prodrug well tolerated; extensive conversion to active moiety TP0178894 with CSF penetration.source ↗
Competitive landscape
Other companies developing against Taisho Pharmaceutical Co., Ltd.'s targets or indications.
- Alto Neuroscience, Inc.3 compoundsH3 receptorMajor depressive disorderTreatment-resistant depression
- Axsome Therapeutics, Inc.2 compoundsMajor depressive disorderNarcolepsy
- Beckley Psytech Limited2 compoundsMajor depressive disorderTreatment-resistant depression
- COMPASS Pathways plc1 compoundMajor depressive disorderTreatment-resistant depression
- Sanofi1 compoundV1B receptorMajor depressive disorder
- Takeda Pharmaceutical Company Limited2 compoundsOX2 receptorNarcolepsy
- Alkermes plc1 compoundNarcolepsy
- Atai Beckley N.V. (AtaiBeckley)1 compoundTreatment-resistant depression
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Biohaven Ltd.1 compoundMajor depressive disorder
- Boehringer Ingelheim International GmbH2 compoundsMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.1 compoundMajor depressive disorder