APREPITANT
Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist used in combination with other antiemetic agents to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly and moderately emetogenic cancer chemotherapy in patients 12 years of age and older. It is also indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Aprepitant is not intended for the treatment of established nausea and vomiting or for chronic, continuous administration.
How APREPITANT Works
Aprepitant is a selective, high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. It crosses the blood-brain barrier to occupy central NK1 receptors, inhibiting the emetic signals triggered by cytotoxic chemotherapeutic agents. While it has little to no affinity for serotonin (5-HT3), dopamine, or corticosteroid receptors, aprepitant augments the antiemetic activity of 5-HT3 receptor antagonists and corticosteroids to inhibit both the acute and delayed phases of chemotherapy-induced emesis.
Details
- Status
- None (Tentative Approval)
- First Approved
- 2012-09-24
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- INJECTION, EMULSION, CAPSULE, EMULSION, INJECTABLE
APREPITANT Approval History
What APREPITANT Treats
2 indicationsAPREPITANT is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
APREPITANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 APREPITANT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
APREPITANT FDA Label Details
Indications & Usage
APREPITANT is indicated for the treatment of Nausea; Vomiting.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.