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Research Report
Solrikitug: An Investigational Thymic Stromal Lymphopoietin Modulator for Immune-Mediated Diseases
I. Introduction to Solrikitug
A. Overview of Solrikitug
Solrikitug is an investigational therapeutic agent, classified as a new molecular entity, currently under development for the treatment of various immune-mediated diseases.[1] It is a human Immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody.[3] The medication is also identified by the alternative names MK-8226 and NSI-8226.[1] The designation as a "New Molecular Entity" is significant as it highlights its novel pharmacological characteristics and potential to introduce a therapeutic mechanism distinct from currently available treatments.[1] This status is a critical consideration for regulatory authorities and for evaluating its innovative contribution to medicine, as it implies a drug containing an active moiety not previously approved, often suggesting a novel mechanism or substantial structural differences that could lead to new therapeutic avenues and potentially distinct efficacy or safety profiles.
B. Originator and Current Developer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/10 | Phase 1 | Recruiting | Uniquity One (UNI) | ||
2024/07/11 | Phase 2 | Recruiting | Uniquity One (UNI) | ||
2012/11/22 | Phase 1 | Terminated |
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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