Overview
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis. The FDA withdrew its approval for the use of all intravenous drug products containing more than 16 mg of ondansetron hydrochloride in a single dose, due to a high risk of QT prolongation.
Indication
In the adult patient population: i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and - the prevention and treatment of postoperative nausea and vomiting ii) intravenously administered ondansetron injection formulations are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and - the prevention and treatment of postoperative nausea and vomiting In the pediatric (4-18 years of age) patient population: i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting, ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger, iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting In the geriatric (>65 years of age) patient population: i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population
Associated Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Cholestatic pruritus
- Post Operative Nausea and Vomiting (PONV)
- Radiation-Induced Nausea and Vomiting
- Uremic Pruritus
- Severe Hyperemesis gravidarum
Research Report
A Comprehensive Monograph on Ondansetron (DB00904)
Section 1: Drug Identification and Physicochemical Properties
This section provides a definitive overview of the chemical and physical characteristics of ondansetron, establishing its identity for pharmaceutical, clinical, and research purposes.
1.1 Nomenclature and Identifiers
Ondansetron is a small molecule drug classified pharmacologically as a serotonin 5-HT3 receptor antagonist and an antiemetic.[1] For clarity in research and clinical practice, it is crucial to recognize its various identifiers.
- Generic Name: Ondansetron [1]
- DrugBank Accession Number: DB00904 [1]
- CAS Numbers: The Chemical Abstracts Service (CAS) has assigned distinct numbers to ondansetron and its common salt forms, a point of potential confusion that requires careful differentiation.
- Parent Compound (Base): 99614-02-5 [3]
- Hydrochloride Salt: 99614-01-4 [5]
- Hydrochloride Dihydrate Salt: 103639-04-9 [5]
- Systematic Chemical Name: 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one [3]
- Synonyms and Research Codes: The compound has been known by several codes throughout its development and research history, including GR 38032, GR 38032F, GR 38032X, and NSC 665799.[3]
- Other Key Identifiers:
- European Community (EC) Number: 619-449-4 [6]
- UNII (Unique Ingredient Identifier): 4AF302ESOS [2]
- Harmonized System (HS) Code: 293329 [9]
- UN Number (for transport): UN2811, indicating it is classified as a dangerous good for transport.[4]
1.2 Chemical Structure and Properties
The molecular structure of ondansetron is the basis for its pharmacological activity. It is a carbazole derivative containing a chiral center, which gives rise to stereoisomers with distinct properties.[2]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/11/17 | Phase 1 | Completed | |||
2021/10/28 | Phase 2 | Completed | Women and Infants Hospital of Rhode Island | ||
2021/10/21 | Phase 3 | Completed | |||
2021/10/13 | Not Applicable | Completed | Tehsil Headquarter Hospital | ||
2021/10/04 | Phase 3 | Terminated | Spectrum Health - Lakeland | ||
2021/08/16 | Phase 4 | UNKNOWN | Aya Sabry Mohamed Mohamed | ||
2021/07/30 | Phase 4 | Withdrawn | |||
2021/05/18 | Early Phase 1 | Completed | |||
2021/05/04 | Phase 3 | UNKNOWN | |||
2021/05/03 | Phase 4 | UNKNOWN | Saint-Joseph University |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Redpharm Drug, Inc. | 67296-1137 | ORAL | 4 mg in 1 1 | 2/7/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-0591 | ORAL | 8 mg in 1 1 | 11/30/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6080 | INTRAMUSCULAR, INTRAVENOUS | 2 mg in 1 mL | 4/1/2022 | |
| St. Mary's Medical Park Pharmacy | 60760-636 | ORAL | 4 mg in 1 1 | 12/8/2023 | |
| BluePoint Laboratories | 68001-246 | ORAL | 4 mg in 1 1 | 2/10/2022 | |
| Clinical Solutions Wholesale, LLC | 58118-7500 | ORAL | 4 mg in 1 1 | 9/3/2020 | |
| Proficient Rx LP | 63187-199 | ORAL | 8 mg in 1 1 | 3/1/2024 | |
| Fosun Pharma USA Inc. | 72266-123 | INTRAMUSCULAR, INTRAVENOUS | 2 mg in 1 mL | 1/31/2023 | |
| Northwind Pharmaceuticals, LLC | 51655-933 | ORAL | 4 mg in 1 1 | 5/16/2023 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0073 | ORAL | 4 mg in 1 1 | 1/19/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ondansetron Hydrochloride Injection | 国药准字H20066474 | 化学药品 | 注射剂 | 7/30/2021 | |
| Ondansetron Hydrochloride Injection | 国药准字H20056409 | 化学药品 | 注射剂 | 6/15/2020 | |
| Ondansetron Hydrochloride Injection | 国药准字H20055086 | 化学药品 | 注射剂 | 9/30/2020 | |
| Ondansetron Hydrochloride Injection | 国药准字H19980115 | 化学药品 | 注射剂 | 12/23/2020 | |
| Ondansetron Hydrochloride Injection | 国药准字H20243751 | 化学药品 | 注射剂 | 5/21/2024 | |
| Ondansetron Hydrochloride Injection | 国药准字H19980012 | 化学药品 | 注射剂 | 8/13/2020 | |
| Ondansetron Hydrochloride Injection | 国药准字H20055769 | 化学药品 | 注射剂 | 3/25/2020 | |
| Ondansetron Hydrochloride Injection | 国药准字H20046058 | 化学药品 | 注射剂(注射液) | 1/6/2021 | |
| Ondansetron Hydrochloride Injection | 国药准字H20046059 | 化学药品 | 注射剂(注射液) | 1/6/2021 | |
| Ondansetron Hydrochloride Injection | 国药准字H20067400 | 化学药品 | 注射剂 | 9/9/2021 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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