Overview
Aramchol has been used in trials studying the treatment of HIV, Gallstones, Fatty Liver, Metabolic Syndrome, and Nonalcoholic Steatohepatitis, among others.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Analysis of the Third-Generation Platinum Antineoplastic Agent: Lobaplatin
Executive Summary
Lobaplatin is a third-generation, organometallic platinum-based antineoplastic agent, classified as a small molecule, that represents a significant evolution in the development of platinum chemotherapy.[1] It functions as a DNA alkylating pro-drug; following intravenous administration and intracellular hydrolysis, it forms highly reactive platinum complexes that create covalent inter- and intra-strand cross-links with DNA. This process inhibits DNA replication and transcription, ultimately leading to cell cycle arrest and apoptosis.[2]
The drug holds exclusive marketing approval in China for the treatment of small cell lung cancer (SCLC), inoperable metastatic breast cancer, and chronic myelogenous leukemia (CML).[2] Clinical trials have demonstrated its non-inferiority to cisplatin in SCLC but with a markedly improved safety profile, and it has shown exceptional promise in triple-negative breast cancer (TNBC), where its addition to neoadjuvant chemotherapy more than doubled the rate of total pathological complete response.[5]
Lobaplatin's primary clinical advantage is its differentiated safety profile compared to first- and second-generation platinum agents. It exhibits significantly lower incidences of nephrotoxicity, neurotoxicity, and severe gastrointestinal toxicity, which are the dose-limiting factors for cisplatin.[3] This improved tolerability is offset by a different primary toxicity: dose-limiting thrombocytopenia.[2] While its global approval is restricted, Lobaplatin's unique profile as a potent and better-tolerated alternative to older platinum agents warrants further investigation, particularly in patient populations intolerant to cisplatin and in settings of platinum resistance.
Chemical Identity and Physicochemical Properties
Nomenclature and Standard Identifiers
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/13 | Phase 1 | Active, not recruiting | |||
2023/10/23 | Phase 2 | Withdrawn | |||
2023/05/24 | Phase 1 | Completed | |||
2020/07/21 | Phase 1 | Completed | |||
2019/09/26 | Phase 3 | Suspended | |||
2018/12/12 | Phase 1 | Completed | |||
2018/11/30 | Phase 1 | Completed | |||
2016/06/17 | Phase 1 | Completed | |||
2016/02/18 | Phase 2 | Completed | |||
2015/02/27 | Phase 1 | Completed |
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 |
|---|---|---|---|---|---|
| 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.