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Research Report
An In-Depth Analysis of the Investigational Drug MK-51: Pharmacological Profile, Corporate Strategy, and Therapeutic Landscape
Executive Summary
This report provides a comprehensive analysis of the investigational drug MK-51, a small molecule, topical spray formulation of a potent corticosteroid currently in Phase 2 clinical development for the treatment of inflammatory skin diseases. The originator of this compound is the German specialty company MIKA Pharma GmbH, which has operated as a subsidiary of the Italian pharmaceutical firm Giuliani S.p.A. since its acquisition in 2010.[1]
A primary challenge addressed within this report is the significant nomenclature collision surrounding the "MK-51" designation. The term is widely and erroneously associated with disparate entities, including military hardware such as the Mark 51 Fire Control System, internal drug development codes from major pharmaceutical companies like Merck & Co., industrial chemicals, and various other unrelated items. A foundational objective of this analysis is to definitively resolve this ambiguity, isolating the MIKA Pharma compound as the correct subject of investigation.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/23 | Phase 1 | Active, not recruiting | |||
2024/10/23 | Not Applicable | Recruiting | |||
2024/02/07 | Phase 3 | Active, not recruiting | |||
2023/09/21 | Phase 2 | Recruiting | |||
2023/08/01 | Phase 4 | Recruiting | Wang Mo | ||
2023/06/23 | Phase 4 | Recruiting | Chinese SLE Treatment And Research Group | ||
2023/05/11 | Not Applicable | Recruiting | |||
2023/03/10 | Phase 3 | Not yet recruiting | |||
2022/11/04 | Phase 4 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2022/09/01 | N/A | Active, not recruiting | Premier Specialists, Australia |
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. | |||||
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