TheraRadar
Data updated: May 26, 2026

APONVIE (aprepitant)

Neurokinin 1 Antagonists Trial Activity: Declining 3 active trials
Gastrointestinal Approved 2022-09-16

Aponvie helps adult patients avoid nausea and vomiting following surgical procedures. It is used as a preventive measure before symptoms begin, as it has not been studied to manage established cases of sickness. This medication provides a targeted approach to postoperative care by focusing on specific pathways in the central nervous system.

Source: FDA Label • HERON THERAPS INC • Substance P/Neurokinin-1 Receptor Antagonist
Jump to: Indications Approvals Trials Competitors Safety Patents

How APONVIE Works

This drug works by crossing the blood-brain barrier to block substance P/neurokinin 1 (NK1) receptors. By binding to these specific targets in the brain, it inhibits the signals that trigger the vomiting reflex. It performs this action selectively, without interacting with the serotonin or dopamine receptors targeted by other common therapies.

Source: FDA Label

Development Insights

Merck Sharp & Dohme LLC conducting 4 trials (9%)
46 indications explored (Broad Platform)
→ vomiting (6 trials)
→ chemotherapy-induced nausea and vomiting (5 trials)
→ nausea (5 trials)
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Prescription
First Approved
2022-09-16
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
EMULSION

Companies

HERON THERAPS INC
Active Ingredient: APREPITANT

APONVIE Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2024 · 1 indication expansions
Mar 2024 SUPPL
Label · Labeling
FDA Letter Label
Sep 2022 ORIGINAL
New Indication · Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
FDA Letter Label

What APONVIE Treats

2 indications

APONVIE is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Postoperative nausea
  • Postoperative vomiting
Source: FDA Label

APONVIE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

FOCINVEZ
STERISCIENCE
2023 2 indic.
VARUBI
TERSERA
2015 2 indic.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

LYNKUET
Bayer
2025 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BARHEMSYS
ACACIA
2020 1 indic.
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
AILEX PHARMS
2018 7 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

45 trials
Trial Sponsor ID Phase Status Title
NCT06357234 APRE-2023 Ph 2 recruiting Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
NCT04649229 2000028712 Ph 4 completed Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3
NCT03718039 results posted HTX-011-218 Ph 2 completed Phase 2 Bunionectomy HTX-011 Administration Study
NCT07371728 2026-4646 Ph 4 not yet recruiting Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery
NCT04606264 STUDY19030022 Ph 3 completed Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
NCT01963793 iTAPP results posted LP0066-1019 Ph 2 completed Topical Aprepitant in Prurigo Patients
NCT05841849 2023-0277 Ph 4 not yet recruiting Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of CINV in Breast Cancer
NCT01298193 results posted GEICAM/2009-02 2010-022689-29 Ph 4 completed Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.
NCT03674294 CINV Aprepitant-CINV Ph 3 completed Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy
NCT02336750 Fudan BR2014-15 CBCSG019 Ph 3 completed Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis
NCT01334086 results posted AML-11-001 Ph 2 completed Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
NCT02770378 CUSP9v3 Ph 1, Ph 2 completed A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma
NCT01527994 09-0457 5R01DA027151-02 Ph 1 completed Aprepitant Effects in Intravenous Heroin Dependence
NCT02646020 EGFR-TKIs TAPE001 Ph 2 completed Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment
NCT00819039 results posted 0869-148 2008_569, 2008-003178-17 Ph 1 completed A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
NCT00588835 ACE UMCN-AKF 07.02 EudraCTnr 2007-003347-73 Ph 4 terminated Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
NCT03572829 CH-RCS-004 Ph 2 completed Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
NCT02161991 ACINV Ph 3 completed Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers
NCT01183481 results posted RINV Prophylaxis Ph 2 terminated Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
NCT03219710 PRaCTiCE IECPG-151/26.04.2017 Ph 3 completed "Olanzapine for Prevention of Chemotherapy Induced Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC)"
NCT01149369 APRON results posted IND - DK-GpCRC-4APRON U01DK073983, U01DK073975 Ph 2 completed Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
NCT02989467 16-007929 Ph 1 completed Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
NCT01732458 results posted 0869-219 2011-006006-27 Ph 2 completed A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)
NCT01636947 KMEC results posted 0869-225 MK-0869-225 Ph 4 completed A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)
NCT01450826 results posted Pro00031206 Ph 2 completed Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide
NCT00970905 AVERT VCC 0908 Ph 2 completed Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Upper Abdominal Radiotherapy
NCT02154360 Emend-IV UPenn 819693 Ph 1 completed Pharmacokinetic Characteristics and Anti-Inflammatory Effects of Aprepitant In HIV-Infected Subjects
NCT02210195 results posted DA030988-04S1 R01DA030988-04S1 Ph 2 completed Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
NCT00952341 results posted 0869-169 2009_626 Ph 3 completed Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
NCT01625455 results posted 110806 Ph 4 terminated Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
NCT01611948 results posted DA030988 5R01DA030988-05 Ph 2 completed Treatment for Cannabis Withdrawal and Dependence
NCT01249001 1000019462 Ph 2 terminated Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Adolescents
NCT02484911 AOPDPCINV results posted GHYDZ-1225 Ph 3 completed Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
NCT02097823 results posted 1401283326 Ph 2 completed Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy
NCT01432015 results posted GOA-NVM1 Ph 4 completed Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
NCT01300988 811938 U01MH090325 Ph 1 completed Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals. 375 mg Dose
NCT02525848 PONV IRB00008718/ reference no. 104 Ph 2, Ph 3 completed Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
NCT00896038 results posted 090136 09-AA-0136 Ph 2 completed The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD
NCT02357693 PONV CEP 280/12 Ph 4 completed Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
NCT00954941 results posted 2008-0615 NCI-2009-01517 Ph 2 completed Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
NCT01402024 Aprepitant CT/38/011/RS Ph 3 completed Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy
NCT01376297 results posted NETU-10-29 Ph 3 completed A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
NCT01897337 3-2012-0076 Ph 4 completed The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
NCT00869973 IGAR-02-2009 2008-001237-95 Ph 3 terminated Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients
NCT01683552 AprepIt Aprepitant-Itch Ph 2 completed Aprepitant in the Management of Biological Therapies-related Severe Pruritus
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

APONVIE FDA Label Details

Indications & Usage

FDA Label (PDF)

APONVIE is indicated for the treatment of Postoperative nausea; Postoperative vomiting.

View full patent landscape →
14 OB patents · 2 families · 44 international docs across 6 countries

APONVIE Patents & Exclusivity

Latest Patent: Sep 2035

Patents (14 active)

US10953018 Expires Sep 18, 2035
US10624850 Expires Sep 18, 2035
US9974794 Expires Sep 18, 2035
US9808465 Expires Sep 18, 2035
US9561229 Expires Sep 18, 2035
US11744800 Expires Sep 18, 2035
US11878074 Expires Sep 18, 2035
US10500208 Expires Sep 18, 2035
US9974793 Expires Sep 18, 2035
US12290520 Expires Sep 18, 2035
US12115254 Expires Sep 18, 2035
US9974742 Expires Sep 18, 2035
US11173118 Expires Sep 18, 2035
US12115255 Expires Sep 18, 2035
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for APONVIE

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 14 active patents

Trial Analysis

  • • 45 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA216457 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment