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Research Report
TLN-254: An Investigational Oral Agent for Relapsed/Refractory T-Cell Lymphomas
1. Introduction to TLN-254
Overview: TLN-254 is an investigational small molecule drug candidate administered orally, currently undergoing early-stage clinical evaluation for the treatment of various hematologic malignancies, with a particular emphasis on T-cell lymphomas.[1] As an investigational agent, TLN-254 has not yet received marketing authorization from regulatory agencies such as the U.S. Food and Drug Administration (FDA).[2] The development of TLN-254 is being spearheaded by Treeline Biosciences, Inc..[1]
Therapeutic Area: The primary therapeutic focus for TLN-254 is within oncology, specifically targeting relapsed or refractory (R/R) T-cell lymphomas.[1] This group of diseases includes challenging conditions such as Peripheral T-cell Lymphoma (PTCL), Anaplastic Large Cell Lymphoma (ALCL), and Cutaneous T-cell Lymphoma (CTCL), encompassing subtypes like Sézary syndrome and mycosis fungoides.[1] T-cell lymphomas are characterized by their aggressive nature and often poor prognoses, particularly in patients whose disease has returned after prior treatments or has become resistant to standard therapies. The consistent targeting of these R/R T-cell lymphoma populations across the early development program for TLN-254 [1] signals a deliberate strategic effort by Treeline Biosciences. This focus aligns with the company's stated mission of addressing "difficult to drug" targets in areas of significant unmet medical need.[14] By concentrating on these hard-to-treat cancers, Treeline Biosciences appears to be leveraging its scientific approach to make a meaningful clinical impact where existing therapeutic options are limited.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2025/07/24 | Not Applicable | Recruiting | |||
2024/12/13 | Phase 1 | Recruiting |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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