ondansetron
Trade name: zofran
Small moleculeapproved
Approved
Jan 4, 1991
Ondansetron (ZOFRAN®) is a selective 5-HT3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by radiotherapy, anesthesia, surgery or cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. It is not certain whether ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex. — NCATS
Clinical trial activity
439 trials · 366 clinical orgs · 43 marketing orgs
Phase 1
68
Phase 2
165
Phase 3
82
Phase 4
100
Earliest trial started May 1, 1998 (NCT00000289)
Timeline
1990s
2000s
- Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
- Feb 26, 2004
Hospira — Marketing Organization
- Nov 22, 2006
Teva — Marketing Organization
- Dec 26, 2006
Fresenius — Marketing Organization
- Dec 26, 2006
Hikma — Marketing Organization
- Dec 26, 2006
Lutipold — Marketing Organization
- Dec 26, 2006
Chartwell Pharmaceuticals — Marketing Organization
- Dec 26, 2006
Dr. Reddy's Laboratories — Marketing Organization
- Dec 26, 2006
Pliva — Marketing Organization
- Dec 26, 2006
West-Ward Pharmaceutical — Marketing Organization
- Dec 26, 2006
Wockhardt — Marketing Organization
- Dec 26, 2006
Daiichi Sankyo — Marketing Organization
- Mar 26, 2007
Sagent Pharmaceuticals, Inc. — Marketing Organization
- May 23, 2007
Nesher Pharms — Marketing Organization
- Jun 25, 2007
Glenmark Pharmaceuticals — Marketing Organization
- Jun 25, 2007
Apotex — Marketing Organization
- Jun 25, 2007
Barr Laboratories — Marketing Organization
- Jun 25, 2007
CASI Pharmaceuticals, Inc. — Marketing Organization
- Jun 25, 2007
Mylan — Marketing Organization
- Jun 25, 2007
Natco Pharma — Marketing Organization
- Jun 25, 2007
Pharmaceutical Associates — Marketing Organization
- Jun 25, 2007
PHARMOBEDIENT — Marketing Organization
- Jul 31, 2007
Aurobindo Pharma — Marketing Organization
- Aug 2, 2007
Sun Pharmaceuticals — Marketing Organization
- Aug 13, 2007
Sandoz — Marketing Organization
- Nov 30, 2007
Taro Pharmaceuticals — Marketing Organization
- Apr 23, 2008
STERISCIENCE — Marketing Organization
- Apr 23, 2008
ONESOURCE SPECIALTY — Marketing Organization
- Nov 18, 2008
Sankyo — Marketing Organization
- Sep 25, 2009
Gland Pharma Ltd — Marketing Organization
2010s
- Apr 14, 2010
Lannett Company, Inc. — Marketing Organization
- Apr 16, 2010
Emcure — Marketing Organization
- Apr 16, 2010
Avet Lifesciences — Marketing Organization
- Jul 2, 2010
Midatech Pharma — Marketing Organization
- Jul 2, 2010
Midatech Pharma — NDA Secondary Org
- Jul 2, 2010
Aquestive Therapeutics — Marketing Organization
- Jul 2, 2010
Aquestive Therapeutics — NDA Secondary Org
- Jan 31, 2011
Amneal Pharmaceuticals — Marketing Organization
- Dec 21, 2012
Eugia Pharma — Marketing Organization
- Feb 22, 2013
Baxalta — Marketing Organization
- Jan 23, 2014
IPCA Laboratories Ltd. — Marketing Organization
- Sep 8, 2014
Qilu Pharmaceutical Co., Ltd. — Marketing Organization
- Jul 13, 2015
Accord Research — Marketing Organization
- Jul 31, 2017
Rising Pharmaceuticals — Marketing Organization
Indications
Studied for
- Abdominal Pain · Phase 4
- Alcoholism · Phase 4
- alpha 1-Antitrypsin Deficiency · Phase 1
- Alzheimer Disease · Phase 2
- Amphetamine-Related Disorders · Phase 2
- Analgesia · Phase 3
- Analgesics · Phase 4
- Analgesics, Opioid · Phase 4
- Anesthesia · Phase 4
- Anesthesia, Caudal · Phase 4
- Anesthesia, Epidural · Phase 3
- Anesthesia, General · Phase 3
- Anesthesia, Obstetrical · Phase 4
- Anesthesia, Spinal · Phase 4
- Antiemetics · Phase 4
- Antineoplastic Agents · Phase 2/Phase 3
- Anxiety · Phase 4
- Arthralgia · Phase 3
- Atrial Fibrillation · Phase 4
- Bariatric Surgery · Phase 3
- Behavior · Phase 4
- Bile Duct Neoplasms · Phase 2
- Bipolar Disorder · Phase 4
- Body Temperature Changes · Phase 4
- Brain Concussion · Phase 1
- Brain Diseases · Phase 1
- Brain Injuries, Traumatic · Phase 1
- Brain Neoplasms · Phase 2
- Breast Diseases · Phase 3
- Breast Neoplasms · Phase 4
- Bronchitis · Phase 3
- Burkitt Lymphoma · Phase 2
- Caffeine · Phase 3
- Cannabis · Phase 4
- Cardiac Output · Phase 2
- Cardiac Output, Low · Phase 4
- Cervical Intraepithelial Neoplasia · Phase 2
- Cesarean Section · Phase 4
- Chills · Phase 4
- Chlorzoxazone · Phase 4
- Cholangiocarcinoma · Phase 2
- Cholecystectomy, Laparoscopic · Phase 4
- Cholecystitis · Phase 4
- Cholelithiasis · Phase 4
- Chronic Pain · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognition Disorders · Phase 4
- Colonic Neoplasms · Phase 2/Phase 3
- Colorectal Neoplasms · Phase 2
- Colorectal Surgery · Phase 3
- Constipation · Phase 4
- Dehydration · Phase 4
- Depression · Phase 2
- Dexmedetomidine · Phase 3
- Diabetes Mellitus · Phase 2
- Diagnosis, Dual (Psychiatry) · Phase 4
- Diarrhea · Phase 4
- Drug Administration Schedule · Phase 2
- Drug Interactions · Phase 3
- Drug Overdose · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Dyspepsia · Phase 2
- Dyspnea · Early Phase 1
- Emergence Delirium · Phase 1
- Endoscopy · Phase 4
- Fasting · Phase 1
- Fractures, Bone · Phase 4
- Gabapentin · Phase 3
- Gallbladder Neoplasms · Phase 2
- Gallstones · Phase 4
- Gastrectomy · Phase 3
- Gastric Emptying · Phase 2
- Gastritis · Phase 3
- Gastroenteritis · Phase 4
- Gastrointestinal Hemorrhage · Phase 4
- Gastrointestinal Neoplasms · Phase 1/Phase 2
- General Surgery · Phase 3
- Genital Neoplasms, Female · Phase 3
- Glioma · Phase 2
- Headache · Phase 4
- Healthy Volunteers · Phase 3
- Heart · Phase 4
- Heart Diseases · Phase 4
- Hematologic Diseases · Phase 2
- Hemodynamics · Phase 4
- Hernia, Inguinal · Phase 4
- HIV Infections · Phase 4
- Hodgkin Disease · Phase 2
- Hyperemesis Gravidarum · Phase 2
- Hypotension · Phase 4
- Infections · Phase 3
- Inflammatory Bowel Diseases · Phase 4
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 3
- Intestinal Pseudo-Obstruction · Phase 4
- Intestines · Phase 4
- Irritable Bowel Syndrome · Phase 4
- Ketamine · Phase 3
- Laparoscopy · Phase 4
- Leukemia · Phase 3
- Leukemia, Eosinophilic, Acute · Phase 2
- Leukemia, Hairy Cell · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Leukemia, Neutrophilic, Chronic · Phase 2
- Lewy Body Disease · Phase 2
- Lidocaine · Phase 3
- Liver Cirrhosis · Phase 1
- Lymphoma · Phase 4
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Mental Health · Phase 2
- Methamphetamine · Phase 2
- Multiple Myeloma · Phase 3
- Myasthenia Gravis · Phase 2
- Mycobacterium avium Complex · Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Narcotic-Related Disorders · Phase 2
- Narcotics · Phase 4
- Neoadjuvant Therapy · Phase 2
- Neonatal Abstinence Syndrome · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 4
- Neoplastic Cells, Circulating · Phase 2
- Nephrolithotomy, Percutaneous · Early Phase 1
- Neuralgia · Phase 1/Phase 2
- Neuroblastoma · Phase 2
- Obesity, Morbid · Phase 3
- Obsessive-Compulsive Disorder · Phase 4
- Ondansetron · Phase 4
- Only Child · Phase 2/Phase 3
- Ovarian Neoplasms · Phase 2
- Oximetry · Phase 3
- Pain · Phase 4
- Pancreatic Diseases · Phase 3
- Pancreatic Neoplasms · Phase 3
- Parkinson Disease · Phase 2
- Pathologic Processes · Phase 3
- Pediatrics · Phase 3
- Personal Satisfaction · Phase 4
- Pharmacokinetics · Phase 3
- Poisoning · Phase 4
- Post-Concussion Syndrome · Early Phase 1
- Post-Dural Puncture Headache · Phase 4
- Postoperative Complications · Phase 4
- Postoperative Pain · Phase 4
- Precancerous Conditions · Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Pregnancy · Phase 2/Phase 3
- Pregnancy Complications · Phase 2
- Primary Myelofibrosis · Phase 2
- Prostatic Neoplasms · Phase 4
- Pruritus · Phase 4
- Psychological Distress · Phase 4
- Psychotic Disorders · Phase 2
- Quality of Life · Phase 2/Phase 3
- Radiotherapy · Phase 2
- Rectal Neoplasms · Phase 2
- Respiratory Distress Syndrome · Phase 4
- Respiratory Insufficiency · Phase 3
- Sarcoma · Phase 2
- Schizophrenia · Phase 3
- Scoliosis · Phase 4
- Sepsis · Phase 1/Phase 2
- Sezary Syndrome · Phase 2
- Shivering · Phase 4
- Shock, Septic · Phase 1/Phase 2
- Sleep Apnea, Obstructive · Phase 3
- Sleep Apnea Syndromes · Phase 3
- Syncope · Phase 2
- Testicular Neoplasms · Phase 2
- Therapeutic Uses · Phase 3
- Tic Disorders · Phase 4
- Tobacco Use Disorder · Phase 2
- Tonsillectomy · Phase 3
- Tonsillitis · Phase 2
- Tourette Syndrome · Phase 4
- Tremor · Phase 4
- Trigeminal Neuralgia · Phase 4
- Uterine Cervical Neoplasms · Phase 3
- Vagus Nerve · Phase 2
- Vomiting · Phase 4
- Weight Loss · Phase 4
Mechanism of action
- Serotonin 3a (5-HT3a) receptorANTAGONIST
HTR3A antagonist
Selective
Approval history
- approvedPriority reviewJan 4, 1991
Chemistry & pharmacology
Loading structure…
SMILES
Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O.Cl.O.O- Mol. weight
- 365.86 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3186492 ↗
- WikipediaOndansetron ↗
- NCATS4AF302ESOS ↗
- ChEMBLCHEMBL46 ↗
- ChEMBLCHEMBL1201111 ↗
Also known as
- demorem
- desmethylondansetron
- desmethylondansetron
- gr-38032
- gr-38032
- gr38032f
- gr-38032f
- gr-38032f
- gr-38032f
- gr-38032f
- gr-38032f
- gr-38032f
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron
- ondansetron hcl
- ondansetron hcl
- ondansetron hcl
- ondansetron hydrochloride
- ondansetron hydrochloride
- ondansetron hydrochloride
- ondansetron hydrochloride
- ondansetron hydrochloride
- ondansetron hydrochloride dihydrate
- ondemet
- ondemet
- setofilm
- setofilm
- zofran
- zofran
- zofran
- zofran
- zofran odt
- zofran odt
- zuplenz
- zuplenz
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07283705 | Phase 2 | May 18, 2026 | Bristol-Myers Squibb, University of Texas at Houston |
| NCT07255404 | Phase 2 | Dec 31, 2025 | Biontech, Bristol-Myers Squibb |
| NCT07246070 | Phase 2 | Dec 31, 2025 | Chinese Academy of Medical Sciences, Henan Medical University |
| NCT07114861 | Phase 1/Phase 2 (Phase 2) | Oct 22, 2025 | — |
| NCT07166601 | Phase 1 | Oct 10, 2025 | Merck KGaA, Merck Serono |
| NCT07044453 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2025 | Rouen Normandy University |
| NCT07155629 | Phase 3 | Sep 1, 2025 | University of Helsinki, University of Oulu |
| NCT07201883 | Phase 1 | Aug 22, 2025 | Makassed General Hospital |
| NCT07088601 | Phase 4 | Aug 10, 2025 | Cairo University |
| NCT07037654 | N/A | Jun 1, 2025 | Suez Canal University |
| NCT06818812 | Phase 1 | Mar 27, 2025 | Incyte |
| NCT07217600 | Phase 4 | Mar 25, 2025 | Chongqing Medical University |
| NCT06861010 | Phase 3 | Mar 20, 2025 | Tanta University |
| NCT06886230 | Phase 4 | Mar 20, 2025 | Lahore Medical and Dental college |
| NCT06850740 | N/A | Mar 15, 2025 | Suez Canal University |
| NCT06810882 | N/A | Feb 16, 2025 | Tanta University |
| NCT06810531 | Phase 4 | Feb 5, 2025 | Suez Canal University |
| NCT06812728 | Phase 2 | Jan 25, 2025 | Menoufia University |
| NCT07087925 | N/A | Jan 15, 2025 | Universitas Sumatera Utara |
| NCT06795594 | N/A | Jan 5, 2025 | Capital Medical University |
Showing 20 of 439 trials
Page 1 / 22
Organizations
Research & Development (366)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 30 | 21 | 5 | 2002 |
| National Cancer Institute (NCI) | Government | 13 | 3 | 4 | 1999 |
| GlaxoSmithKline | For profit | 12 | 9 | 5 | 2003 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Government | 10 | 2 | 3 | 1999 |
| Tanta University | Academic/Hospital | 9 | 9 | 4 | 2021 |
| University of Calgary | Academic/Hospital | 8 | 7 | 4 | 2014 |
| University of Virginia | Academic/Hospital | 8 | 4 | 3 | 2005 |
| Algorithme Pharma Inc | For profit | 7 | 0 | 1 | 2002 |
| Duke University | Academic/Hospital | 7 | 6 | 4 | 2007 |
| University of Texas at Houston | Academic/Hospital | 7 | 7 | 3 | 2005 |
| Assiut University | Academic/Hospital | 6 | 6 | 2 | 2016 |
| Cairo University | Academic/Hospital | 6 | 6 | 3 | 2016 |
| National Institute on Drug Abuse (NIDA) | Government | 6 | 3 | 2 | 1998 |
| Par Pharmaceuticals | For profit | 6 | 6 | 2 | 2002 |
| Stanford University | Academic/Hospital | 6 | 6 | 3 | 2008 |
| University of Maryland | Academic/Hospital | 6 | 6 | 2 | 2005 |
| University of Montreal | Academic/Hospital | 6 | 3 | 4 | 2013 |
| Seoul National University | Academic/Hospital | 5 | 4 | 2 | 2009 |
| University of British Columbia | Academic/Hospital | 5 | 5 | 2 | 2008 |
| University of Copenhagen | Academic/Hospital | 5 | 5 | 2 | 2012 |
366 organizations
Page 1 / 19
Marketing (67)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Jul 13, 2015 |
| Amneal Pharmaceuticals | For profit | MKTG | Jan 31, 2011 |
| Apotex | For profit | MKTG | Jun 25, 2007 |
| Apotex | For profit | SYN | Dec 26, 2006 |
| Aquestive Therapeutics | For profit | MKTG | Jul 2, 2010 |
| Aquestive Therapeutics | For profit | NDA2 | Jul 2, 2010 |
| Aurobindo Pharma | For profit | MKTG | Jul 31, 2007 |
| Aurobindo Pharma | For profit | SYN | Dec 21, 2012 |
| Avet Lifesciences | For profit | MKTG | Apr 16, 2010 |
| Barr Laboratories | For profit | MKTG | Jun 25, 2007 |
| Baxalta | For profit | MKTG | Feb 22, 2013 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Jun 25, 2007 |
| Chartwell Pharmaceuticals | For profit | MKTG | Dec 26, 2006 |
| Chartwell Pharmaceuticals | For profit | SYN | Apr 14, 2010 |
| Chartwell Pharmaceuticals | For profit | SYN | Jun 25, 2007 |
| Daiichi Sankyo | For profit | MKTG | Dec 26, 2006 |
| Dr. Reddy's Laboratories | For profit | MKTG | Dec 26, 2006 |
| Emcure | For profit | SYN | Jan 3, 2013 |
| Emcure | For profit | MKTG | Apr 16, 2010 |
| Eugia Pharma | For profit | MKTG | Dec 21, 2012 |
| Fresenius | For profit | MKTG | Dec 26, 2006 |
| Gland Pharma Ltd | For profit | MKTG | Sep 25, 2009 |
| GlaxoSmithKline | For profit | NDA2 | Jan 31, 1995 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jun 25, 2007 |
| Glenmark Pharmaceuticals | For profit | SYN | Jun 25, 2007 |
| Hikma | For profit | MKTG | Dec 26, 2006 |
| Hikma | For profit | SYN | Sep 6, 2007 |
| Hikma | For profit | SYN | Dec 26, 2006 |
| Hikma | For profit | SYN | Dec 26, 2006 |
| Hospira | For profit | MKTG | Feb 26, 2004 |
| IPCA Laboratories Ltd. | For profit | MKTG | Jan 23, 2014 |
| Lannett Company, Inc. | For profit | MKTG | Apr 14, 2010 |
| Lutipold | For profit | MKTG | Dec 26, 2006 |
| Midatech Pharma | For profit | MKTG | Jul 2, 2010 |
| Midatech Pharma | For profit | NDA2 | Jul 2, 2010 |
| Mylan | For profit | MKTG | Jun 25, 2007 |
| Mylan | For profit | SYN | Apr 23, 2008 |
| Natco Pharma | For profit | MKTG | Jun 25, 2007 |
| Nesher Pharms | For profit | MKTG | May 23, 2007 |
| Novartis | For profit | MKTG | Jan 4, 1991 |
| Novartis | For profit | NDA2 | Jan 4, 1991 |
| Novartis | For profit | NDA | Jan 4, 1991 |
| ONESOURCE SPECIALTY | For profit | MKTG | Apr 23, 2008 |
| PHARMOBEDIENT | For profit | MKTG | Jun 25, 2007 |
| Pharmaceutical Associates | For profit | MKTG | Jun 25, 2007 |
| Pliva | For profit | MKTG | Dec 26, 2006 |
| Qilu Pharmaceutical Co., Ltd. | For profit | SYN | Sep 8, 2014 |
| Qilu Pharmaceutical Co., Ltd. | For profit | MKTG | Sep 8, 2014 |
| Qilu Pharmaceutical Co., Ltd. | For profit | MKTG | Sep 8, 2014 |
| Rising Pharmaceuticals | For profit | MKTG | Jun 25, 2007 |
| Rising Pharmaceuticals | For profit | MKTG | Jul 31, 2017 |
| STERISCIENCE | For profit | MKTG | Apr 23, 2008 |
| STERISCIENCE | For profit | SYN | Apr 23, 2008 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Mar 26, 2007 |
| Sandoz | For profit | MKTG | Aug 13, 2007 |
| Sandoz | For profit | SYN | Jun 27, 2007 |
| Sandoz | For profit | NDA2 | Jan 4, 1991 |
| Sankyo | For profit | MKTG | Nov 18, 2008 |
| Sun Pharmaceuticals | For profit | SYN | Dec 26, 2006 |
| Sun Pharmaceuticals | For profit | SYN | Dec 26, 2006 |
| Sun Pharmaceuticals | For profit | MKTG | Aug 2, 2007 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 30, 2007 |
| Taro Pharmaceuticals | For profit | SYN | Mar 21, 2008 |
| Teva | For profit | MKTG | Nov 22, 2006 |
| West-Ward Pharmaceutical | For profit | MKTG | Dec 26, 2006 |
| Wockhardt | For profit | MKTG | Dec 26, 2006 |
| Wockhardt | For profit | SYN | Dec 26, 2006 |