Drugs / fosaprepitant dimeglumine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | EMEND | — | 2010-11-12 – 2022-05-02 | fda.gov ↗ |
| Approved | US (FDA) | EMEND | — | 2008-01-25 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00990821 | Jan → Dec 2005 | chemotherapy-induced toxicity | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00895245 | Feb 2009 → Sep 2010 | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, lip and oral cavity squamous cell carcinoma, nasopharyngeal squamous cell carcinoma +1 | University of Washington | Terminated | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT04468646 | Jun → Jul 2020 | — | Prof. Dr. Fridoon Jawad Ahmad | Unknown | No outcome recorded |
| Phase 3 | NCT01594749 | Sep 2012 → Nov 2014 | chemotherapy-induced toxicity | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00337727 | Jan 2007 → Oct 2008 | chemotherapy-induced toxicity | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00231777 | Jul → Nov 2005 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04054193 | Sep 2019 → Feb 2021 | chemotherapy-induced toxicity | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05755659 | Jul 2022 → Oct 2024 | neoplasm | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT01504711 | Jun 2012 → Dec 2016 | chemotherapy-induced toxicity, digestive system cancer | Philip Philip | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02732015 Comparator | Oct 2016 → Jul 2020 | sarcoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT07081256 Comparator | Jan → Aug 2025 | chemotherapy-induced toxicity | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-02-04 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC) merck.com ↗
With this approval, EMEND for injection is the first intravenous single-dose NK 1 receptor antagonist approved in the U.S. for both highly emetogenic chemotherapy (HEC) as well as MEC. |
| 2015-06-29 | Merck Sharp & Dohme LLC | Results Merck Announces Phase 3 Study of Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection Regimen Met Primary Endpoint in Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy merck.com ↗ |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fosaprepitant dimeglumine | “Aprepitant capsules may be given to patients from 3-5 days fosaprepitant dimeglumine (Injection 115mg, prodrug form of aprepitant) may be substituted for oral drug in case of...” NCT04468646 ↗ |
| Known as | MK-0517 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00990821 ↗ |
| Action | Inhibit | “This product is a NK-1 receptor antagonist” NCT05755659 ↗ |
| Route | Intravenous | “by IV” NCT00231777 ↗ |