ORCA-T

Phase 2Small molecule

OOrca Biosystems, Inc.

ORCA-T is one of 90 small molecule programs targeting Myelodysplastic Syndrome. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaRecruiting

Leukemia, Myeloid, AcuteRecruiting

Myelodysplastic SyndromePhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Recruiting

Leukemia, Myeloid, AcutePhase 2

Recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

32 2

Vepesid

AAvyxa

Phase 3

50 3

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

31 4

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 5

Cytoxan

BBaxter Healthcare Corporation

Phase 3

28 6

Clolar

GGenzyme, a Sanofi Company

Phase 3

21 7

Peony

Takeda

Phase 3

6 8

Novantrone

EMD Serono

Phase 3

19 9

Empaveli

Gilead

Phase 3

4 10

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06551584

Q2 2027

Phase 1Active, not recruiting

Hematologic Malignancies

NCT04013685

Q4 2028

Phase 2Recruiting

Leukemia, Myeloid, Acute

NCT07216443

Clinical

Trials by Indication[1]

Hematologic Malignancies2 trials

Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting·OOrca Biosystems, Inc.·Phase 1·NCT04013685·255 enrolled

Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Active, not recruiting·OOrca Biosystems, Inc.·Phase 3·NCT05316701·187 enrolled

Advanced Hematologic Malignancies1 trial

Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies

Temporarily not available·OOrca Biosystems, Inc.··NCT07346105

Leukemia, Myeloid, Acute1 trial

A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting·OOrca Biosystems, Inc.·Phase 2·NCT07216443·80 enrolled

Acute Myeloid Leukemia1 trial

Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7/8) With Orca-T

Recruiting·SStanford University·Phase 1·NCT06551584·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for ORCA-T. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ORCA-T compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ORCA-T. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Orca Biosystems, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: OOrca Biosystems, Inc.

ORCA-T

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2028

Trials by Indication[1]

Hematologic Malignancies2 trials

Advanced Hematologic Malignancies1 trial

Leukemia, Myeloid, Acute1 trial

Acute Myeloid Leukemia1 trial

References

Drug Info

Quick Facts

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