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Takara Bio Inc. (JP:4974)
:4974
Cyclophosphamide, Fludarabine, Tbi-1301
Synovial Sarcomas
Phase III
Not Yet Recruiting
Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma
Sep 12, 2025
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Gemcitabine, Nab-paclitaxel, Tbi-1401(Hf10), Ts-1
Pancreatic Cancer Stage Iv, Pancreatic Cancer Stage Iii
Phase I
Active Not Recruiting
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patients with Unresectable Pancreatic Cancer.
Aug 09, 2017
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Cyclophosphamide, Tbi-1301
Synovial Sarcoma
Phase I/II
Completed
Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients with Synovial Sarcoma
Aug 08, 2017
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Ipilimumab, Tbi-1401(Hf10)
Melanoma Stage Iii, Melanoma Stage Iv
Phase II
Completed
A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma
May 08, 2017
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Tbi-1501
Lymphoblastic Leukemia, Acute Adult
Phase I/II
Active Not Recruiting
Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Apr 14, 2017
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Takara Bio Inc. (4974) have in its pipeline
4974 is currently developing the following drugs: Cyclophosphamide, Fludarabine, Tbi-1301, Gemcitabine, Nab-paclitaxel, Tbi-1401(Hf10), Ts-1, Cyclophosphamide, Tbi-1301. These drug candidates are in various stages of clinical development as the company works toward FDA approval.