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 · a red edge is where a trial was stopped

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Phase 0 NCT03035838 Nov 2021 → Dec 2022 traumatic brain injury Arun Gupta Withdrawn No outcome recorded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
Phase 1 NCT04636632 Nov 2020 → Nov 2022 nasopharyngeal carcinoma Sun Yat-sen University Completed No outcome recorded
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
Phase 1/21 trial
Phase 1/2 NCT01031953 Aug 2008 → Feb 2013 OHSU Knight Cancer Institute Terminated No outcome recorded
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
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
Phase 2/31 trial
Phase 2/3 NCT06382012 Nov 2024 → Mar 2027 expected Montefiore Medical Center Recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT05564286 Jul 2021 → Jul 2023 cervical cancer, chemotherapy-induced toxicity, nasopharyngeal carcinoma Shantou University Medical College Completed No outcome recorded
Phase 3 NCT04853147 Apr 2021 → Apr 2022 Sixth Affiliated Hospital, Sun Yat-sen University Completed No outcome recorded
Phase 3 NCT03578081 Nov 2018 → Nov 2021 cancer Alliance for Clinical Trials in Oncology Completed No outcome recorded
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 No outcome recorded
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
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 No outcome recorded
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 No outcome recorded
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
Also used as a comparator or background therapy in 21 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
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 23 trials
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 No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03606369 Background Nov 2015 → Jul 2018 breast neoplasm National Cancer Institute of Mexico Unknown No outcome recorded
Phase 313 trials
Phase 3 NCT07413809 Comparator Oct 2025 → Sep 2027 expected plasma cell myeloma The Affiliated People's Hospital of Ningbo University Recruiting No outcome recorded
Phase 3 NCT07124195 Background Aug 2025 → Oct 2026 expected cancer, chemotherapy-induced toxicity The First Affiliated Hospital of Xinxiang Medical College Not yet recruiting No outcome recorded
Phase 3 NCT06200168 Background Jan 2024 → Oct 2026 expected Jiuda Zhao Recruiting No outcome recorded
Phase 3 NCT05509634 Comparator Sep 2022 → Jun 2023 Fujian Shengdi Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT05242874 Background Feb 2022 → Aug 2023 chemotherapy-induced toxicity Henan Cancer Hospital Completed No outcome recorded
Phase 43 trials
Phase 4 NCT05841849 Comparator Jul 2023 → Jul 2028 expected breast cancer, chemotherapy-induced toxicity Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 4 NCT03586817 Comparator Mar 2019 Bonsucesso Federal Hospital Unknown No outcome recorded
Phase 4 NCT01432015 Comparator Sep 2011 → Mar 2015 ovarian cancer, uterine cancer Gynecologic Oncology Associates Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 51 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
48

“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

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

FosaprepitantNCT04503668

NCT06382012

NCT01405924

NCT05881486

NCT01649258

NCT03197064

NCT05564286

NCT06904235

NCT02106494

NCT02780609

NCT03586817

NCT04636632

NCT05230654

NCT01111851

NCT05773950

NCT04873284

NCT01857232

NCT02116530

NCT00818259

NCT05841849

NCT01697579

NCT02407600

NCT00619359

NCT01874119

NCT01344304

NCT05509634

NCT06740812

NCT04853147

NCT05242874

NCT01432015

NCT04508400

NCT01031953

NCT03578081

NCT04912271

NCT04536558

NCT03035838

NCT07413809

NCT02519842

NCT01490060

NCT03237611

NCT01074697

NCT01736917

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