fosnetupitant

Trade name: Akynzeo

Small moleculeapproved

Approved

Apr 19, 2018

Fosnetupitant is a prodrug form of netupitant. Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK-1) receptors. Upon intravenous administration, fosnetupitant is converted by phosphatases to its active form. It competitively binds to and blocks the activity of NK-1 receptors in the central nervous system, by inhibiting binding of substance P (SP) to NK-1 receptors. This prevents delayed emesis, which is associated with SP secretion. AKYNZEO® is a combination of palonosetron, a serotonin-3 receptor antagonist, and netupitant (capsules for oral use) or fosnetupitant (injections for intravenous use). AKYNZEO® for injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. — NCATS

Clinical trial activity

2 trials · 4 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Mar 16, 2018 (NCT03403712)

Timeline

2010s

  1. Jan 1, 2018

    Helsinn — Earliest Phase 3 Sponsor(trial)

  2. Apr 19, 2018

    Helsinn — Earliest FDA Approval

  3. Apr 19, 2018

    Helsinn — NDA Secondary Org

  4. Apr 19, 2018

    Helsinn — NDA Organization

2020s

  1. Jan 1, 2023

    Helsinn — Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedApr 19, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CN(C(=O)C(C)(C)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F)C2=C(C=C(N=C2)N3CC[N+](C)(COP(O)([O-])=O)CC3)C4=C(C)C=CC=C4
Mol. weight
688.5976 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Prodrug

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06840769Phase 1Jun 17, 2023Cross Research S.A., Helsinn
NCT03403712Phase 3Mar 16, 2018George Clinical Pty Ltd, Helsinn, PSI CRO
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
HelsinnFor profit2222018
Cross Research S.A.For profit1012023
George Clinical Pty LtdAcademic/Hospital1012018
PSI CROFor profit1012018
4 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
HelsinnFor profitNDA2Apr 19, 2018
HelsinnFor profitNDAApr 19, 2018