Drugs / Netupitant
Netupitant
also known as
NETU · Netupitant component of akynzeo · Netupitant component of akynzeo capsule · RO 67-3189/000 · RO-67-3189
Small molecule targets TACR1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Akynzeo | — | 2015-05-27 | europa.eu ↗ |
| Approved | US (FDA) | AKYNZEO | — | 2014-10-10 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 missed | ||||||
| Phase 2/3 | NCT03040726 | May 2017 → Feb 2022 | cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 32 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 4 | NCT03831633 | Sep 2018 → Jul 2019 | — | VIFORFRANCE | Unknown | No outcome recorded |
| Comparator or background therapy4 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 4 | NCT07254416 Background | Dec 2025 → Dec 2026 expected | — | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-18 | Helsinn Healthcare SA | Regulatory Helsinn announces European Commission approval of AKYNZEO® Oral Suspension helsinn.com ↗
Lugano, Switzerland – February 18th, 2026 – Helsinn Healthcare SA (“Helsinn”), a global pharmaceutical group focused on supporting patients with cancer and chronic diseases, today announced that the European Commission (EC) has granted marketing authorization for the new oral suspension formulation of AKYNZEO® (netupitant/palonosetron) on 12th of February 2026. |
| 2025-10-17 | Helsinn Healthcare SA | Results Results from the MyRisk clinical trial, accepted for publication in the Annals of Oncology, will be presented today at ESMO 2025 as an oral presentation helsinn.com ↗
The primary endpoint was met; patients receiving AKYNZEO® were significantly more likely to achieve a complete response (CR: no emesis and no use of rescue medication) than those in the SOC arm in the overall phase (0-120 h after |
| 2023-02-03 | Helsinn Healthcare SA | Results Helsinn announces publication of new data evaluating impact of NEPA (netupitant/palonosetron) on hospital costs helsinn.com ↗
Results from the study indicate that CINV-related hospitalization costs were significantly lower in patients who received NEPA compared to aprepitant/fosaprepitant with ondansetron (APON) or aprepitant/fosaprepitant with palonosetron (APPA) (P <.0001 for both comparisons). |
| 2023-01-04 | Helsinn Healthcare SA | Results Helsinn publishes results from a secondary analysis of a Phase 3 trial in patients with CINV in The Oncologist helsinn.com ↗
The analysis indicated that patients who experienced CR in their first cycle had a 93% or higher CR rates in subsequent cycles. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-18 | Helsinn Healthcare SA | Helsinn announces European Commission approval of AKYNZEO® Oral Suspension helsinn.com ↗ |
| 2025-10-17 | Helsinn Healthcare SA | Results from the MyRisk clinical trial, accepted for publication in the Annals of Oncology, will be presented today at ESMO 2025 as an oral presentation helsinn.com ↗ |
| 2023-02-03 | Helsinn Healthcare SA | Helsinn announces publication of new data evaluating impact of NEPA (netupitant/palonosetron) on hospital costs helsinn.com ↗ |
| 2023-01-04 | Helsinn Healthcare SA | Helsinn publishes results from a secondary analysis of a Phase 3 trial in patients with CINV in The Oncologist helsinn.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 ↗ |