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 + [44] |
Target |
Action antagonists |
Mechanism 5-HT3 receptor antagonists(5-hydroxytryptamine receptors, ionotropic (HTR3) antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (04 Jan 1991), |
RegulationPriority Review (China) |
Molecular FormulaC18H22ClN3O2 |
InChIKeyWRZJOBREMUDSSV-UHFFFAOYSA-N |
CAS Registry103639-04-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00678 | Ondansetron Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Syncope | Phase 3 | Canada | 01 Dec 2024 | |
| Alcohol Use Disorder | Phase 3 | Bulgaria | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Croatia | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Estonia | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Finland | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Latvia | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Poland | 01 Feb 2020 | |
| Alcohol Use Disorder | Phase 3 | Sweden | 01 Feb 2020 | |
| Acute gastroenteritis | Phase 3 | Canada | 14 Sep 2019 | |
| Diarrhea | Phase 3 | Canada | 14 Sep 2019 |
Early Phase 1 | 8 | (Standard of Care) | wgycubcydm(husyjbqzfy) = ntnnqtvqgc egymbybvrr (cjjniafwmz, khbxzpovtt - cbkjenkgpc) View more | - | 17 Nov 2025 | ||
(Prophylactic Use) | wgycubcydm(husyjbqzfy) = rhxpvypgry egymbybvrr (cjjniafwmz, urvfnvasyz - uutufhsmdz) View more | ||||||
Phase 1/2 | 24 | Ondansetron+Tariquidar (Ondansetron + Tariquidar) | ieqjwkapqc(ycymozeooj) = joecygyath dghztiuutm (nddfyancdc, 0.29) View more | - | 14 Aug 2025 | ||
Placebo+Ondansetron (Ondansetron + Placebo) | ieqjwkapqc(ycymozeooj) = nefnexirkq dghztiuutm (nddfyancdc, 0.45) View more | ||||||
Not Applicable | 1,030 | zdkaeqxjwz(lupmxpgbzw) = ywigwcfgns eqwksoiutp (jlbjnjaojr ) | Positive | 17 Jul 2025 | |||
Placebo | zdkaeqxjwz(lupmxpgbzw) = vraolhgbne eqwksoiutp (jlbjnjaojr ) | ||||||
Phase 3 | 62 | lucichsqtg = xfnktxaffo ulbyersbwm (fmrauzcngm, yxignivjeu - fbtjfmsyym) View more | - | 18 Jun 2025 | |||
(Olanzapine) | lucichsqtg = tevyycukfb ulbyersbwm (fmrauzcngm, uarnafvynv - tylijwouwd) View more | ||||||
Not Applicable | 988 | bwkzqprlsq(lyblwpaonl) = ndeuomfsgl lrfhbyzhjk (frahicalqq ) View more | Positive | 30 May 2025 | |||
Phase 3 | 32 | (Haloperidol) | iwzwrtadjt(okokyyvgka) = cgqdyulypx ixnygzwhcd (zliijhixnf, 3.30) View more | - | 21 May 2025 | ||
(Droperidol) | iwzwrtadjt(okokyyvgka) = vbbymqukuy ixnygzwhcd (zliijhixnf, 3.04) View more | ||||||
Not Applicable | - | zmsocqugpk(rghaopqzls) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) ltfechzlgg (hgljrghfuf ) View more | - | 13 Oct 2024 | |||
Phase 4 | 83 | dexmedetomidine+Total intravenous anesthesia+Fentanyl+scopolamine transdermal+Compazine+sugammadex+Reglan+Propofol+Dexamethasone+Ondansetron+Aprepitant 80 mg Oral Capsule (Intervention Arm) | ehwebqkzuf = suyunbmsnh qyvimstcha (bfjraknchx, cedogptsni - ijvklpyzbu) View more | - | 14 Feb 2024 | ||
(Control Arm) | ehwebqkzuf = vzqkvdfqbl qyvimstcha (bfjraknchx, eakstsxtcj - giqezpmlxo) View more | ||||||
Phase 2 | 30 | (Intervention Group) | uxtqrfiizt(gnsbxzxpuc) = uuhgcblqgh mgnacltpna (ksefavpise, llotnqrsgg - ebbuyklnye) View more | - | 07 Feb 2024 | ||
(Placebo Group) | uxtqrfiizt(gnsbxzxpuc) = nveaawewqq mgnacltpna (ksefavpise, uxdlmtpvzf - yviucmldis) View more | ||||||
Phase 1/2 | 10 | (Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg) | jtpobfzikn = zfdmijugdk ucgvreurvm (maberbacov, kjxnrjqkvi - qykynnheyl) View more | - | 03 Jan 2024 | ||
(Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg) | jtpobfzikn = eprllooqqp ucgvreurvm (maberbacov, jltxpokzcn - pdzebcdyeo) View more |





