Drugs / MK-8237
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | allergic rhinitis | 2016-04-12 | “FDA has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet.” merck.com ↗ “The FDA accepted for review the Biologics License Application (BLA) for MK-8237, the company’s investigational house dust mite sublingual allergy” merck.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT01852825 | Nov 2013 → Jul 2015 | allergic rhinitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT01678807 | Oct 2012 → May 2013 | perennial allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01644617 | Oct 2012 → Aug 2013 | perennial allergic rhinitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01700192 | Jan 2013 → Apr 2015 | perennial allergic rhinitis | ALK-Abelló A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-05-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2016 Financial Results merck.com ↗
The FDA accepted for review the Biologics License Application (BLA) for MK-8237, the company’s investigational house dust mite sublingual allergy immunotherapy tablet. |
| 2016-04-12 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet. |
| 2014-03-04 | Merck Sharp & Dohme LLC | Results Merck Announces Results from Phase 2b Study of MK-8237, an Investigational House Dust Mite Sublingual Allergen Immunotherapy Tablet merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-05-05 | Merck Sharp & Dohme LLC | Merck Announces First-Quarter 2016 Financial Results merck.com ↗ |
| 2016-04-12 | Merck Sharp & Dohme LLC | Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet merck.com ↗ |
| 2014-03-04 | Merck Sharp & Dohme LLC | Merck Announces Results from Phase 2b Study of MK-8237, an Investigational House Dust Mite Sublingual Allergen Immunotherapy Tablet merck.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MK-8237 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01678807 ↗ |
| Route | Other | “administered sublingually” NCT01644617 ↗ |