Otsuka Holdings Co., Ltd. (4578.T) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Otsuka Holdings Co., Ltd., built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.

For informational purposes only — not investment advice. Track 4578.T live on Mooboard →

Next 30 days1

  • Oct 20, 2026
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    SEP-363856 · Phase 3 · Schizophrenia
    NCT06894212: A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia. Primary completion 2026-10-20 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

31–90 days1

  • Dec 2026
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    OPA-15406 · Phase 3 · Atopic Dermatitis (AD)
    NCT07173478: A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis. Primary completion 2026-12 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗

Later22

  • Feb 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    OPA-15406 · Phase 3 · Atopic Dermatitis (AD)
    NCT07184645: A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis. Primary completion 2027-02 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 13, 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Sibeprenlimab · Phase 2 · Sjogren Disease
    NCT06928142: A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's. Primary completion 2027-03-13 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • May 27, 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Centanafadine XR · Phase 3 · Attention-deficit/Hyperactivity Disorder; Emotional Dysregulation
    NCT07759154: A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation. Primary completion 2027-05-27 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 28, 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    BPaQM · Phase 3 · Pulmonary Tuberculosis
    NCT07209761: A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis. Primary completion 2027-05-28 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 30, 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    OPF-310 · Phase 1 / Phase 2 · Diabetes Mellitus, Type 1; Hypoglycemia
    NCT06575426: A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus. Primary completion 2027-06-30 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    EB-1020 (Centanafadine) low dose · Phase 2 / Phase 3 · Attention-Deficit Hyperactivity Disorder(ADHD)
    NCT07086313: A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD. Primary completion 2027-08 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    EB-1020 (Centanafadine) low dose · Phase 3 · Attention-Deficit Hyperactivity Disorder(ADHD)
    NCT07087327: A Long-term Trial of EB-1020 in Pediatric Patients With ADHD. Primary completion 2027-08 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    OPC-34712FUM/ Brexpiprazole fumarate · Phase 3 · Acute Schizophrenia
    NCT05325645: Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia. Primary completion 2027-09 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 1, 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    JNT-517 · Phase 3 · Phenylketonuria (PKU)
    NCT06628128: A Long-Term Study of JNT-517 in Participants With Phenylketonuria. Primary completion 2027-11-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    EB-1020 (Centanafadine) 164.4 mg · Phase 3 · Attention Deficit Hyperactivity Disorder (ADHD)
    NCT06926829: A Long-term Trial of EB-1020 in Adult Patients With ADHD. Primary completion 2027-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2027
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    EB-1020 (Centanafadine) 164.4 mg · Phase 2 / Phase 3 · Attention Deficit Hyperactivity Disorder (ADHD)
    NCT06931080: Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients. Primary completion 2027-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 31, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Software as a Medical Device · Phase 2 / Phase 3 · Post-Traumatic Stress Disorder, PTSD
    NCT06589505: Software as a Medical Device for the Treatment of Patients With PTSD. Primary completion 2028-01-31 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Feb 28, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Drug:5-ALA, Device:Photodynamic system · Phase 1 / Phase 2 · Adult T-Cell Leukemia/Lymphoma (ATLL)
    NCT07075328: A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma. Primary completion 2028-02-28 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    SEP-363856 · Phase 3 · Schizophrenia
    NCT07225712: A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia. Primary completion 2028-03 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 1, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    JNT-517 Tablet · Phase 3 · Phenylketonuria
    NCT06971731: A Study of JNT-517 in Participants With Phenylketonuria (PKU). Primary completion 2028-03-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 31, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Tolvaptan Suspension · Phase 3 · Autosomal Recessive Polycystic Kidney (ARPKD)
    NCT04782258: A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD). Primary completion 2028-07-31 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 25, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    SEP-363856 · Phase 3 · Generalized Anxiety Disorder
    NCT07767903: A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder. Primary completion 2028-10-25 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 6, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    SEP-363856 · Phase 3 · Generalized Anxiety Disorder
    NCT07759128: A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder. Primary completion 2028-12-06 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 28, 2028
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Sibeprenlimab 400 mg s.c. Q4weeks · Phase 2 / Phase 3 · Immunoglobulin A Nephropathy
    NCT05248659: Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN). Primary completion 2028-12-28 (estimated); status ENROLLING_BY_INVITATION.
    ClinicalTrials.gov ↗
  • Apr 17, 2029
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Sibeprenlimab · Phase 2 · IgA Nephropathy
    NCT06740526: Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue. Primary completion 2029-04-17 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 26, 2029
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    SEP-363856 · Phase 3 · Generalized Anxiety Disorder
    NCT07786454: A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder. Primary completion 2029-05-26 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 29, 2029
    Otsuka Holdings Co., Ltd.(4578.T)Phase 2/3 readout
    Sibeprenlimab · Phase 3 · IgA Nephropathy
    NCT07770815: Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN). Primary completion 2029-12-29 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗

How Otsuka Holdings Co., Ltd. has moved — past-year price reactions

How binary is 4578.T? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.

1.3%
typical day (1Y)
0
±10% days
32.2%
annualized vol
242
trading days
Largest single-day moves
  • +8.7%2026-07-02no matched headline
  • +7.2%2026-02-13no matched headline
  • +6.8%2026-03-11no matched headline
  • +5.2%2025-10-01no matched headline
  • +5.2%2026-05-29no matched headline
  • +5%2026-04-28no matched headline

Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.

Otsuka Holdings Co., Ltd. — active clinical pipeline

Otsuka Holdings Co., Ltd.'s registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.

22 assets26 programsPh1 7Ph2 4Ph3 15
AreasOncologyAutoimmuneImmunologyMetabolicNeuroscienceInfectiousOther
SibeprenlimabAutoimmune · TNFSF13
Phase 2
IgA NephropathySjogren Disease
Phase 3
IgA Nephropathy
SEP-363856Neuroscience · HTR1A/TAAR1
Phase 3
Generalized Anxiety Disorder (3)Schizophrenia (2)
BPaQMInfectious
Phase 3
Pulmonary Tuberculosis
Centanafadine XROther
Phase 3
Attention-deficit/Hyperactivity Disorder
EB-1020 (Centanafadine) 164.4 mgOther
Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) (2)
EB-1020 (Centanafadine) low doseOther
Phase 3
Attention-Deficit Hyperactivity Disorder(ADHD) (2)
JNT-517Other
Phase 3
Phenylketonuria (PKU)
JNT-517 TabletOther
Phase 3
Phenylketonuria
OPA-15406Immunology · PDE4A
Phase 3
Atopic Dermatitis (AD) (2)
OPC-34712FUM/ Brexpiprazole fumarateNeuroscience
Phase 3
Acute Schizophrenia
Sibeprenlimab 400 mgOther · TNFSF13
Phase 3
Immunoglobulin A Nephropathy
Sibeprenlimab 400 mg s.c. Q4weeksOther · TNFSF13
Phase 3
Immunoglobulin A Nephropathy
Subcutaneous azacitidineOncology
Phase 3
Myelodysplastic Syndromes
Tolvaptan SuspensionOther
Phase 3
Autosomal Recessive Polycystic Kidney (ARPKD)
IV DecitabineOncology
Phase 2
Myelodysplastic Syndromes
Ponatinib 30mg ODOncology
Phase 2
Chronic Myeloid Leukemia
RepinatrabitOther
Phase 1
Healthy volunteersPhenylketonuria
14C-SEP-380135Neuroscience
Phase 1
Schizophrenia
ASTX727Oncology
Phase 1
Lower-risk Myelodysplastic
HBM7020Autoimmune
Phase 1
Rheumatoid Arthritis
NDI-5001Metabolic
Phase 1
Diabetes Insipidus
VIS171Autoimmune
Phase 1
Systemic Lupus Erythematosus (SLE)

Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).

Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built

See the full biopharma catalyst calendar across all covered companies.