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    Otsuka Holdings
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    2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo 101-0048
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    • Development Update
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    Otsuka and Lundbeck Announce FDA Acceptance for Brexpiprazole in PTSD Treatment

    Details:

    Rexulti (brexpiprazole) is an partial agonist of serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


    Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: H. Lundbeck AS

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 25, 2024

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    Ionis Expands Licensing Agreement with Otsuka for Donidalorsen in Hereditary Angioedema

    Details:

    Ionis entered into a license agreement with Otsuka & obtained exclusive rights across the Asia-Pacific region for IONIS-PKK-LRx (donidalorsen) for treating hereditary angioedema.


    Lead Product(s): Donidalorsen

    Therapeutic Area: Genetic Disease Product Name: IONIS-PKK-LRx

    Highest Development Status: Phase IIIProduct Type: Large molecule

    Recipient: Ionis Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: $20.0 million

    Deal Type: Licensing Agreement June 18, 2024

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    Otsuka to Terminate Development of AVP-786

    Details:

    Termination of development of the novel compound AVP-786 (deudextromethorphan HBr), in development for the treatment of agitation associated with dementia due to Alzheimer's.


    Lead Product(s): Deudextromethorphan Hydrobromide,Quinidine sulphate

    Therapeutic Area: Neurology Product Name: AVP-786

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 22, 2024

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    Otsuka and Lundbeck Submit sNDA for FDA Review of Brexpiprazole and Sertraline Combination as Potential Treatment for PTSD

    Details:

    Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


    Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: H. Lundbeck AS

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 09, 2024

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    Otsuka and Lundbeck Submit sNDA for FDA Review of Brexpiprazole and Sertraline Combination as Potential Treatment for PTSD

    Details:

    Rexulti (brexpiprazole) 5-HT2A receptor, is being evaluated in combination with sertraline in late-stage clinical trials with adult patients for the treatment of post-traumatic stress disorder.


    Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Product Name: Rexulti

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: H. Lundbeck AS

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 09, 2024

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    Abilify Maintena® 960mg (aripiprazole) Approved in the EU as the First Once-Every-two-months Long-acting Injectable for The Maintenance Treatment of Sc...

    Details:

    Abilify Maintena (aripiprazole) is an atypical antipsychotic that works as a D2 and 5-HT1A receptors partial agonist. It is approved for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.


    Lead Product(s): Aripiprazole

    Therapeutic Area: Psychiatry/Psychology Product Name: Abilify Maintena

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 27, 2024

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    Novartis Receives Approval in Japan for Entresto® Granular Tablets for Pediatric Use, a Formulation Dedicated for Pediatric Patients with Chronic Heart...

    Details:

    Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: Entresto

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Novartis Pharmaceuticals Corporation

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 26, 2024

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    Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment

    Details:

    OPC-167832 (quabodepistat) is a potent and orally active dprE1 inhibitor, which is being evaluated in combination with delamanid & bedaquiline for the treatment of pulmonary tuberculosis.


    Lead Product(s): OPC-167832,Delamanid,Bedaquiline

    Therapeutic Area: Infections and Infectious Diseases Product Name: OPC-167832

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 22, 2024

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    Otsuka and Sumitomo Revise License Agreement

    Details:

    Under the license agreement, Otsuka holds exclusive rights to develop, manufacture, and commercialize SEP-363856 (ulotaront), TAAR1 agonist. It is being evaluated with the patient for the treatment of Schizophrenia.


    Lead Product(s): Ulotaront

    Therapeutic Area: Psychiatry/Psychology Product Name: SEP-363856

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: Sumitomo Pharma

    Deal Size: $30.0 million Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement March 15, 2024

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    Venetoclax Plus HMA Therapy Shows Encouraging Results in Higher-Risk MDS/CMML

    Details:

    Inqovi is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor. It is being evaluated in combination with venetoclax for the treatment of higher-risk myelodysplastic syndromes & chronic myelomonocytic leukemia.


    Lead Product(s): Decitabine,Cedazuridine,Venetoclax

    Therapeutic Area: Oncology Product Name: Inqovi

    Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Genentech

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 22, 2024

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