Fosaprepitant
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ivemend | — | 2008-01-11 | europa.eu ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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| Phase 0 | NCT03035838 | Nov 2021 → Dec 2022 | traumatic brain injury | Arun Gupta | Withdrawn | No outcome recorded |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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 3 | NCT05244577 Comparator | Jan 2022 → Dec 2023 | malignant testicular germ cell tumor | Shi Yanxia | Unknown | No outcome recorded |
| Phase 3 | NCT04912271 Background | Jun 2021 → Jun 2022 | chemotherapy-induced toxicity | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT04503668 Comparator | Dec 2020 → Jan 2024 | female reproductive organ cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT04536558 Comparator | Oct 2020 → Feb 2021 | chemotherapy-induced toxicity | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 3 | NCT04437017 Comparator | Feb 2020 → May 2022 | chemotherapy-induced toxicity | Fifth Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 3 | NCT02116530 Background | Aug 2014 → Apr 2015 | cancer of unknown primary site, hematopoietic and lymphoid cell neoplasm | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT02106494 Background | Mar 2014 → May 2015 | chemotherapy-induced toxicity | Heron Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01074697 Comparator | Apr 2010 → Apr 2015 | female reproductive system neoplasm | Odense University 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.
| Field | Value | Cited 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 ↗ “Fosaprepitant” NCT04503668 ↗ |
| 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 ↗ |