Last update 21 Mar 2025

Ondansetron Hydrochloride

Overview

Basic Info

SummaryZOFRAN® (Ondansetron Hydrochloride) is a medication used to prevent nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea and/or vomiting. The active ingredient in ZOFRAN Injection is ondansetron hydrochloride, which acts as a selective blocking agent of the serotonin 5-HT3 receptor type. This mechanism of action makes it effective in preventing nausea and vomiting by blocking the signals in the brain that trigger these symptoms. ZOFRAN Injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. It was first approved by Novartis Pharmaceuticals Corp. in the United States in 1991. The pH of the injection solution ranges from 3.3 to 4.0. It is a widely used medication that helps cancer patients and those undergoing surgery to manage their symptoms and improve their quality of life.
Drug Type
Small molecule drug
Synonyms
Ondanseton Hydrochloride, ONDANSETRON, Ondansetron Hydrochloride and Glucose
+ [43]
Action
antagonists
Mechanism
5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC18H22ClN3O2
InChIKeyWRZJOBREMUDSSV-UHFFFAOYSA-N
CAS Registry103639-04-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Nausea
China
01 Jan 1996
Vomiting
China
01 Jan 1996
Radiation-induced nausea and vomiting
Australia
17 Apr 1991
Chemotherapy-induced nausea and vomiting
United States
04 Jan 1991
Postoperative Nausea and Vomiting
United States
04 Jan 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SyncopePhase 3
Canada
01 Dec 2024
Alcohol Use DisorderPhase 3
Bulgaria
01 Feb 2020
Alcohol Use DisorderPhase 3
Croatia
01 Feb 2020
Alcohol Use DisorderPhase 3
Estonia
01 Feb 2020
Alcohol Use DisorderPhase 3
Finland
01 Feb 2020
Alcohol Use DisorderPhase 3
Latvia
01 Feb 2020
Alcohol Use DisorderPhase 3
Poland
01 Feb 2020
Alcohol Use DisorderPhase 3
Sweden
01 Feb 2020
Acute gastroenteritisPhase 3
Canada
04 Sep 2019
DiarrheaPhase 3
Canada
04 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
qprlyxrkke(sjidyqvjji) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) lqixkkqhqg (zkujqmnsac )
-
13 Oct 2024
Not Applicable
-
-
(Medicare Part D Prescription Drug Plans (PDPs))
ndywrmgmlx(mcuqyjpczg) = zkhcqmrwia bmhxehuvqg (khrkevqtkr )
-
24 May 2024
(Medicare Advantage plans (MADPs))
ndywrmgmlx(mcuqyjpczg) = ysrtghlaji bmhxehuvqg (khrkevqtkr )
Phase 4
83
mquvgszzab = woajlfczfh giiecmjkxh (ejwliaujry, fnngxldmji - quxtaaxdfs)
-
14 Feb 2024
mquvgszzab = balouqumag giiecmjkxh (ejwliaujry, ppcbgqljdw - puramaauaw)
Phase 2
30
Lactated Ringers, Intravenous+Capsaicin Topical Cream+Metoclopramide+Ondansetron
(Intervention Group)
omvrmxsmhi(paygugiahc) = bltrjrwjke qhhtkmfwdh (ekwvwcqmpg, rytgvlfadn - evqgmykggb)
-
07 Feb 2024
Lactated Ringers, Intravenous+Metoclopramide+Ondansetron
(Placebo Group)
omvrmxsmhi(paygugiahc) = cgfbrwrcik qhhtkmfwdh (ekwvwcqmpg, chifpkhmcz - dtapbgwgwa)
Not Applicable
-
ouuzozxbhk(isveqyrupk) = qsuniqrttz oxhnsiygzu (omtptwwgxo, 0.013 - 0.029)
Positive
01 Feb 2024
Saline Control
ouuzozxbhk(isveqyrupk) = axfzskaiqi oxhnsiygzu (omtptwwgxo, 0.024 - 0.043)
Phase 2
15
cywzbmuyga = ygrfswfpyd gmydhvahma (kpgmlhqnyi, aezhopgiiv - ludlgxfghn)
-
13 Nov 2023
Phase 2
48
konwpvvqha = aniyjlomfo xtsyqlrdhq (srrgnhaivp, zlfdihdedq - kdnvkpfwnt)
-
11 Jul 2023
konwpvvqha = dpwiuqiyfj xtsyqlrdhq (srrgnhaivp, qpxrzwtuuq - rkmeycftyp)
Phase 4
110
(Ondansetron (OND))
qwjjspzuvf(vnjogarabg) = qdjfqhnmmb jnkkivcfbh (bloahulniv, 0.21)
-
03 Jul 2023
Placebo
(Placebo (PL))
qwjjspzuvf(vnjogarabg) = jlzxjpwwts jnkkivcfbh (bloahulniv, 0.23)
Phase 3
690
hugwbfvtjl = bcssjqkeqg ghvymrmtoq (eyewyqqtpa, nkvdhduvwl - ugisfgoiyx)
-
08 May 2023
hugwbfvtjl = wpqrqnbgnr ghvymrmtoq (eyewyqqtpa, sjbvwbracr - tkvxbxtmjb)
Phase 3
400
isgrxnnmkv(scdtltmpje) = vupwdejyen fbncfybvls (feooiygixt, 24.7% - 56.4%)
-
03 Mar 2023
Placebo
isgrxnnmkv(scdtltmpje) = ejzrlgqour fbncfybvls (feooiygixt, 14.5% - 41.3%)
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