Overview
Tamibarotene is a novel synthetic retinoid for acute promyelocytic leukaemia (APL). Tamibarotene is currently approved in Japan for treatment of recurrent APL, and is undergoing clinical trials in the United States.
Indication
Investigated for use/treatment in leukemia (unspecified).
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Tamibarotene (DB04942): From Acute Promyelocytic Leukemia to Biomarker-Driven Oncology
1.0 Introduction: A Third-Generation Retinoid for Targeted Oncology
1.1 Overview of Tamibarotene as a Synthetic RARα/β Agonist
Tamibarotene, marketed in Japan under the brand name Amnolake, is an orally active, synthetic, third-generation retinoid with significant antineoplastic activity.[1] Classified as a retinobenzoic acid, it is a small molecule designed as a potent and selective agonist for the retinoic acid receptor alpha (
RARα) and retinoic acid receptor beta (RARβ).[2] Its development was a deliberate effort in rational drug design, aimed at creating a therapeutic agent that retains the beneficial cell-differentiating properties of natural retinoids while improving upon their pharmacological and safety profiles.[5] Initially developed for hematologic malignancies, its primary clinical application has been in the treatment of acute promyelocytic leukemia (APL), a distinct subtype of acute myeloid leukemia (AML).[1]
1.2 Rationale for Development: Overcoming the Limitations of ATRA
The scientific impetus for the creation of Tamibarotene stemmed directly from the clinical challenges associated with its predecessor, all-trans retinoic acid (ATRA), a natural retinoid that revolutionized the treatment of APL.[7] While highly effective, ATRA therapy is hampered by several limitations, including chemical instability, the development of clinical resistance, and a pharmacokinetic profile characterized by rapidly declining plasma concentrations during continuous administration.[8] Tamibarotene was specifically engineered to circumvent these issues.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/04 | Phase 2 | Active, not recruiting | |||
2023/10/17 | Phase 1 | Withdrawn | |||
2021/10/01 | Phase 1 | Recruiting | |||
2021/05/27 | Phase 2 | Terminated | |||
2021/03/15 | Phase 3 | Terminated | |||
2016/06/21 | Phase 2 | Completed | |||
2011/04/28 | Phase 2 | UNKNOWN | |||
2011/04/18 | Phase 2 | Terminated | CytRx | ||
2010/10/22 | Phase 2 | UNKNOWN | |||
2010/05/10 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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