TheraRadar
Data updated: Jul 17, 2026

EMEND (fosaprepitant dimeglumine) · Merck

Neurokinin 1 Antagonists
Oncology Approved 2003-03-26

Emend (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and moderately emetogenic cancer chemotherapy (MEC). The oral suspension is indicated for

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

How EMEND Works

This medication works by blocking substance P/neurokinin 1 (NK1) receptors in the brain. By crossing the blood-brain barrier and binding to these specific receptors, it prevents the signals that trigger vomiting during chemotherapy. This action also enhances the effectiveness of other anti-nausea treatments like corticosteroids and serotonin antagonists.

Source: FDA Label
11
Indications
--
Phase 3 Trials
3
Priority Reviews
23
Years on Market

Details

Status
Prescription
First Approved
2003-03-26
Patent Cliff
2027

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS, ORAL
Dosage Forms
POWDER, FOR SUSPENSION, CAPSULE

Companies

Merck
Active Ingredient: FOSAPREPITANT DIMEGLUMINE

EMEND Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
108 FDA actions from 2003 to 2022 · 8 indication expansions
May 2022 SUPPL
Efficacy
FDA Letter Label
Nov 2019 SUPPL
Label · Labeling
FDA Letter Label
Sep 2019 SUPPL
Label · Labeling
FDA Letter Label

What EMEND Treats

2 indications

EMEND is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

EMEND Competitive Set

Pro

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

Direct competitors

4

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

APONVIE
HERON THERAPS
2022 2 indic.
CINVANTI
HERON THERAPS
2017 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
LXO IRELAND
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.

Drugs Similar to EMEND

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Shared indications:
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CASPER PHARMA LLC
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APREPITANT
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2 shared
GLENMARK SPECLT
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Clinical Trial Registry

54 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 results posted STUDY19030022 Ph 3 completed Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
NCT03578081 results posted A221602 NCI-2017-02410, UG1CA189823 Ph 3 completed Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
NCT01963793 iTAPP results posted LP0066-1019 Ph 2 completed Topical Aprepitant in Prurigo Patients
NCT04054193 results posted 0517-045 MK-0517-045, 2018-004844-43 Ph 4 completed Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
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
NCT02732015 results posted 2015-0587 NCI-2016-00801, 2015-0587 Ph 2 terminated Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
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)
NCT01594749 results posted 0517-031 Ph 3 completed Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
NCT01405924 EVADE results posted 0517-030 Ph 2 terminated Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
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
NCT01649258 1B-11-5 NCI-2012-01170 Ph 1 terminated Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
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)
NCT00895245 results posted 6862 NCI-2009-01669 Ph 2 terminated Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
NCT01625455 results posted 110806 Ph 4 terminated Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome
NCT01031953 results posted CDR0000612580 P30CA069533, OHSU-HEM-08053-L Ph 1, Ph 2 terminated Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy
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
NCT01074697 GAND-emesis GAND-emesis 2009-014691-21 Ph 3 completed Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
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

Showing 50 of 54 trials

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Trial Timeline

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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.

EMEND FDA Label Details

Indications & Usage

FDA Label (PDF)

EMEND ® for oral suspension, in combination with other antiemetic agents, is indicated in patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND ® capsules, in combination with other antiemetic agents, is indicated in patients 12 years of age and older for the prevention of: acute and delayed nausea and vomiting ass...

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1 OB patents · 1 families · 64 international docs across 39 countries

EMEND Patents & Exclusivity

Latest Patent: Sep 2027

Patents (1 active)

US8258132 Expires Sep 26, 2027
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2027
  • • 19 active patents

Trial Analysis

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Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022023 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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