Drugs / MK-1293
MK-1293
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | diabetes mellitus, congenital autoimmune | 2016-08-05 | “Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293” merck.com ↗ |
| Filed | EU (EMA) | — | diabetes mellitus, congenital autoimmune | — | “the Marketing Authorization Application for MK-1293, which Merck submitted to the European Medicines Agency in December 2015, is currently under review.” merck.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02059174 | Feb 2014 → Mar 2015 | type 1 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT02059187 | Feb 2014 → Mar 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02059161 | Oct 2013 → May 2015 | type 1 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-08-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine merck.com ↗ |
| 2016-06-13 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus® merck.com ↗
Furthermore, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-07-20 | Merck Sharp & Dohme LLC | Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologic Basal Insulin merck.com ↗ |
| 2016-08-05 | Merck Sharp & Dohme LLC | Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine merck.com ↗ |
| 2016-06-13 | Merck Sharp & Dohme LLC | Merck’s Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus® merck.com ↗ |
| 2016-05-12 | Merck Sharp & Dohme LLC | Merck to Present Phase 3 Data on Investigational Medicines Ertugliflozin and MK-1293 at the 76th Scientific Sessions of the American Diabetes Association merck.com ↗ |
| 2014-02-10 | Merck Sharp & Dohme LLC | Merck and Samsung Bioepis Enter Collaboration Agreement to Develop and Commercialize Insulin Glargine Candidate for Diabetes merck.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MK-1293 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02059161 ↗ |
| Known as | insulin glargine | “AIMS: MK-1293 is an insulin glargine that has an amino acid sequence identical to that of Lantus, the originator insulin glargine.” PMID 28817223 ↗ Sep 20172“MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks.” NCT02059187 ↗ “MK-1293 insulin glargine (Mk-Gla; 100 U/mL)” PMID 29766635 ↗ Jun 2018 |
| Known as | Mk-Gla | “AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM).” PMID 29761615 ↗ Jun 20181“MK-1293 insulin glargine (Mk-Gla; 100 U/mL)” PMID 29766635 ↗ Jun 2018 |
| Modality | Protein / enzyme biologic | “MK-1293 insulin glargine (Mk-Gla; 100 U/mL)” PMID 29766635 ↗ Jun 2018 |
| Route | Subcutaneous | “MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks.” NCT02059161 ↗ |