Drugs / Fosaprepitant

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Ivemend — 2008-01-11 europa.eu ↗

Trials 28

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT06427681 May → Sep 2024 — Zhuhai Beihai Biotech Co., Ltd Unknown No outcome recorded
Phase 0 NCT03035838 Nov 2021 → Dec 2022 traumatic brain injury Arun Gupta Withdrawn No outcome recorded
Phase 14 trials · 1 missed
Phase 1 NCT04636632 Nov 2020 → Nov 2022 nasopharyngeal carcinoma Sun Yat-sen University Completed Missed primary
Phase 1 NCT01649258 Sep 2012 → May 2017 breast cancer University of Southern California Terminated No outcome recorded
Phase 1 NCT01111851 Apr → Oct 2010 chemotherapy-induced toxicity Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00818259 Feb 2009 → Jan 2014 chemotherapy-induced toxicity Merck Sharp & Dohme LLC Terminated No outcome recorded Stop: Enrollment
Phase 1/21 trial
Phase 1/2 NCT01031953 Aug 2008 → Feb 2013 — OHSU Knight Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 27 trials
Phase 2 NCT07692451 Jul 2026 → Jul 2027 expected chemotherapy-induced toxicity Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT04508400 Aug 2022 → Jun 2023 childhood malignant neoplasm Sun Yat-sen University Completed No outcome recorded
Phase 2 NCT03237611 Oct 2018 → Feb 2021 chemotherapy-induced toxicity Albert Einstein College of Medicine Terminated No outcome recorded
Phase 2 NCT01874119 Sep 2013 → Dec 2015 chemotherapy-induced toxicity St. Louis University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01736917 Jan 2013 → Mar 2015 chemotherapy-induced toxicity Lawrence Einhorn Completed No outcome recorded
Phase 2 NCT01697579 Dec 2012 → Nov 2016 chemotherapy-induced toxicity Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT01405924 Oct 2011 → Dec 2013 — Merck Sharp & Dohme LLC Terminated No outcome recorded Stop: Enrollment
Phase 2/31 trial
Phase 2/3 NCT06382012 Nov 2024 → Mar 2027 expected — Montefiore Medical Center Recruiting No outcome recorded
Phase 35 trials · 3 met primary · 1 missed
Phase 3 NCT05564286 Jul 2021 → Jul 2023 cervical cancer, chemotherapy-induced toxicity, nasopharyngeal carcinoma Shantou University Medical College Completed Met primary
Phase 3 NCT04853147 Apr 2021 → Apr 2022 — Sixth Affiliated Hospital, Sun Yat-sen University Completed Met primary
Phase 3 NCT03578081 Nov 2018 → Nov 2021 cancer Alliance for Clinical Trials in Oncology Completed Missed primary
Phase 3 NCT02519842 Sep 2015 → Feb 2017 chemotherapy-induced toxicity Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT00619359 Feb 2008 → Jun 2009 chemotherapy-induced toxicity Merck Sharp & Dohme LLC Completed Met primary
Phase 42 trials
Phase 4 NCT06740812 Dec 2026 → Sep 2027 expected — Montefiore Medical Center Not yet recruiting No outcome recorded
Phase 4 NCT03197064 Jan 2018 → Jan 2020 — Stanford University Completed No outcome recorded
Phase not applicable6 trials · 1 met primary · 1 missed
— NCT05773950 Aug 2023 → Dec 2025 overdue — Samsung Medical Center Enrolling by invitation No outcome recorded
— NCT05881486 Jun 2023 respiratory system disorder Qilu Hospital of Shandong University Unknown Missed primary
— NCT05230654 Feb → Apr 2022 chemotherapy-induced toxicity Shanghai Children's Medical Center Unknown No outcome recorded
— NCT04873284 May → Dec 2021 chemotherapy-induced toxicity, childhood malignant neoplasm Shanghai Children's Medical Center Unknown Met primary
— NCT01490060 May 2012 → Mar 2016 chemotherapy-induced toxicity, sarcoma M.D. Anderson Cancer Center Completed No outcome recorded
— NCT01344304 Apr 2011 → Nov 2013 colorectal cancer Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group Completed No outcome recorded
Comparator or background therapy22 trials
Phase 1/2 NCT02780609 Background Jul 2017 → Feb 2021 plasma cell myeloma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 2 NCT07848984 Background Oct 2026 → Aug 2028 expected breast neoplasm Second Affiliated Hospital, Zhejiang University, School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT06904235 Comparator Jul 2025 → Oct 2027 expected chemotherapy-induced toxicity Helsinn Healthcare SA Recruiting No outcome recorded
Phase 2 NCT02407600 Comparator Apr 2015 → Feb 2018 non-small cell lung carcinoma Ajeet Gajra Unknown No outcome recorded
Phase 2 NCT01857232 Background Oct 2013 → Feb 2015 — Acacia Pharma Ltd Completed Met primary

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2019-09-06 Lupin Limited Regulatory Lupin receives U.S. FDA approval for Fosaprepitant for Injection lupin.com ↗
Pharma major Lupin Limited (Lupin) announced that it has received approval for its Fosaprepitant for Injection, 150 mg Single-Dose Vial, from the United States Food and Drug Administration (U.S. FDA).
2019-05-07 Lupin Limited Regulatory Lupin receives tentative U.S. FDA approval for Fosaprepitant for Injection lupin.com ↗
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 ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

FieldValueCited text
Known as Fosaprepitant “Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV for early emesis and for delayed emesis Dexamethasone 8 mg orally on days 2, 3 and 4.” NCT03606369 ↗
49

“Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg” NCT06200168 ↗

“Active Comparator: Drug:HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug:Palonosetron injection Drug: Dexamethasone” NCT07692451 ↗

“NK-1 receptor antagonists may include fosrolapitant, aprepitant, or fosaprepitant.” NCT07848984 ↗

“Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy” NCT05244577 ↗

“150 mg fosaprepitant intravenously 30 minutes (±1 minute)” NCT06427681 ↗

“Fosaprepitant (administered on Day 1, 150 mg, once daily)” NCT07124195 ↗

“Fosaprepitant: 150 mg intravenously, d1” NCT04437017 ↗

“Fosaprepitant” NCT04503668 ↗

NCT05841849 ↗

NCT05564286 ↗

Show 39 more sources

Known as Emend “EMEND® (fosaprepitant) for injection 150 mg” NCT06427681 ↗
1

“FOSAPREPITANT (Emend)” NCT02407600 ↗

Known as FAPR “HR20013 plus dexamethasone (DEX) versus fosaprepitant (FAPR) plus PALO + DEX” PMID 39621965 ↗ Dec 2024
Known as fosaprepitant dimeglumine “To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy...” NCT01649258 ↗
1

“fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy” NCT05509634 ↗

Known as fosaprepitant dimeglumine for injection “Active Comparator: Drug:HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug:Palonosetron injection Drug: Dexamethasone” NCT07692451 ↗
Known as Fosaprepitant for injection “Fosaprepitant for injection:150 mg fosaprepitant intravenously 30 minutes (±1 minute)” NCT06427681 ↗
Known as IVAMEND “Following this, and within 24 hours from injury, IVAMEND (the intravenous formulation of the NK-1 antagonist fosaprepitant)will be administered at a dose of 300 mg,...” NCT03035838 ↗
Action Inhibit “This study compared a 3-day oral aprepitant schedule to a regimen containing a single dose of the intravenous NK1RA fosaprepitant.” PMID 21383291 ↗ Mar 2011
Modality Other / unclassified “Fosaprepitant is a neurokinin-1 receptor antagonist” NCT04912271 ↗
Route Intravenous “single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.” NCT00619359 ↗