Drugs / Akynzeo
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chemotherapy-induced toxicity 1 milestone | |||||
| Filed | EU (EMA) | AKYNZEO | chemotherapy-induced toxicity | 2025-04-02 | “today announced the submission of a new formulation for AKYNZEO® to the European Medicines Agency (EMA).” helsinn.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Akynzeo | — | 2015-05-27 | europa.eu ↗ |
| Approved | US (FDA) | AKYNZEO | — | 2014-10-10 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04362449 | Jan 2019 → Feb 2023 | gallbladder cancer | Imperial College Healthcare NHS Trust | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03668639 | Sep 2018 → Mar 2023 | cervical cancer, chemotherapy-induced toxicity | Christina Ruhlmann | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06065722 Comparator | Sep → Dec 2023 | chemotherapy-induced toxicity | Simon Williamson Clinic | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| 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 |
| 2025-04-02 | Helsinn Healthcare SA | Regulatory Helsinn Group submits a new formulation of AKYNZEO® to the European Medicines Agency (EMA) helsinn.com ↗
today announced the submission of a new formulation for AKYNZEO® to the European Medicines Agency (EMA). |
| 2023-06-12 | Helsinn Healthcare SA | Results Helsinn announces publication of data evaluating impact of AKYNZEO® (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs helsinn.com ↗
Referring to the details of the publication below, these real-world data showed that healthcare resource utilization, such as CINV-related visits were significantly lower after AKYNZEO® compared to fosaprepitant/palonosetron (APPA). |
| 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 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Akynzeo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03668639 ↗ |
| Action | Inhibit | “Akynzeo contains a combination of the neurokinin-1 receptor antagonist netupitant and the serotonin receptor antagonist palonosetron.” NCT03668639 ↗ |
| Route | Oral | “Akynzeo is administered as an oral drug” NCT04362449 ↗ |