Drugs / Netupitant

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Akynzeo 2015-05-27 europa.eu
Approved US (FDA) AKYNZEO 2014-10-10 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07662200 Aug 2026 → Aug 2027 expected malignant germ cell tumor Ottawa Hospital Research Institute Not yet recruiting No outcome recorded
Phase 25 trials
Phase 2 NCT04669132 Dec 2020 → Dec 2021 chemotherapy-induced toxicity Instituto Brasileiro de Controle do Cancer Completed No outcome recorded
Phase 2 NCT03386617 Feb 2018 → Dec 2027 expected breast cancer Chinese University of Hong Kong Active not recruiting No outcome recorded
Phase 2 NCT03204279 Aug 2017 → Sep 2019 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 2 NCT03097588 Apr 2017 → Feb 2020 cancer OHSU Knight Cancer Institute Completed No outcome recorded
Phase 2 NCT03008213 Jan 2017 → Jan 2018 chemotherapy-induced toxicity Joseph Ma Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03040726 May 2017 → Feb 2022 cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01376297 Jul 2011 → Sep 2012 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT01339260 Apr 2011 → Nov 2012 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06726291 Feb 2024 → Dec 2025 overdue endometrial cancer Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Recruiting No outcome recorded
Phase 4 NCT04817189 Feb 2021 → Jul 2024 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 4 NCT03831633 Sep 2018 → Jul 2019 VIFORFRANCE Unknown No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 33 trials
Phase 3 NCT06331520 Background May 2024 → Aug 2025 chemotherapy-induced toxicity Fudan University Completed No outcome recorded
Phase 3 NCT03403712 Comparator Mar → Sep 2018 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT02517021 Comparator Nov 2015 → Aug 2016 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07254416 Background Dec 2025 → Dec 2026 expected Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as netupitant “Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron” NCT03386617
15

“containing 300 mg netupitant and 0.5 mg palonosetron).” NCT03831633

NCT06726291

NCT01376297

NCT03040726

NCT02517021

NCT06331520

NCT03008213

NCT07662200

NCT01339260

NCT03204279

NCT04817189

NCT03403712

NCT03097588

NCT07254416

NCT04669132

Known as NETU “This post-hoc analysis evaluated the efficacy of NEPA, a fixed combination of netupitant (NETU [NK1RA]) and palonosetron (PALO [5-HT3RA]) in BC patients from two phase III studies.” PMID 28285236 Mar 2017
Known as Netupitant component of akynzeo ChEMBL registry synonym — accepted as the source's own label CHEMBL206253
Known as Netupitant component of akynzeo capsule ChEMBL registry synonym — accepted as the source's own label CHEMBL206253
Known as RO 67-3189/000 ChEMBL registry synonym — accepted as the source's own label CHEMBL206253
Known as RO-67-3189 ChEMBL registry synonym — accepted as the source's own label CHEMBL206253
Action Inhibit “Netupitant and palonosetron are drugs that are thought to block the activation of certain types of chemicals in these areas (brain and gut)” NCT03386617
1

“Neurokinin 1 receptor antagonist” CHEMBL206253

Modality Small molecule CHEMBL206253
Route Oral Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle” NCT01339260
Target TACR1 “Neurokinin 1 receptor antagonist” CHEMBL206253