Alosetron
Lotronex (alosetron) is a small molecule pharmaceutical. Alosetron was first approved as Lotronex on 2000-02-09. It is used to treat abdominal pain, diarrhea, and irritable bowel syndrome in the USA. It is known to target 5-hydroxytryptamine receptor 3A.
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Commercial
Trade Name
FDA
EMA
Lotronex (generic drugs available since 2015-05-04)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOTRONEX | Sebela Pharmaceuticals | N-021107 RX | 2000-02-09 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alosetron hydrochloride | ANDA | 2022-05-25 |
| lotronex | New Drug Application | 2019-05-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| abdominal pain | HP_0002027 | D015746 | R10.9 |
| diarrhea | HP_0002014 | D003967 | R19.7 |
| irritable bowel syndrome | EFO_0000555 | D043183 | K58 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
42 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 1 | 6 | 7 | 2 | 16 |
| Prostatic diseases | D011469 | N42.9 | — | — | — | 1 | 1 | 2 | |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | 1 | 1 | — | 2 | |
| Choroid diseases | D015862 | HP_0000610 | H31.9 | — | — | — | 1 | — | 1 |
| Renal colic | D056844 | EFO_1001412 | N23 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | — | 2 | — | 1 | 3 |
| Neurogenic urinary bladder | D001750 | HP_0000011 | N31 | — | — | 3 | — | — | 3 |
| Urinary retention | D016055 | HP_0000016 | R33 | — | — | 2 | — | 1 | 3 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | 1 | — | 1 | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 1 | — | — | 1 |
| Hydronephrosis | D006869 | EFO_0005562 | N13.30 | — | — | 1 | — | — | 1 |
| Urinary calculi | D014545 | N20.9 | — | — | 1 | — | — | 1 | |
| Prostatic neoplasms | D011471 | C61 | — | — | 1 | — | — | 1 | |
| Ureteral calculi | D014514 | — | — | 1 | — | — | 1 | ||
| Colic | D003085 | HP_0011848 | R10.83 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | — | 1 | — | — | — | 1 |
| Nephrolithiasis | D053040 | N20.0 | — | 1 | — | — | — | 1 | |
| Urolithiasis | D052878 | N20-N23 | — | 1 | — | — | — | 1 | |
| Ureterolithiasis | D053039 | EFO_1001228 | N20.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ALOSETRON |
| INN | alosetron |
| Description | Alosetron is a pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position. It has a role as a serotonergic antagonist, an antiemetic and a gastrointestinal drug. It is a pyridoindole and a member of imidazoles. |
| Classification | Small molecule |
| Drug class | serotonin 5-HT3 receptor antagonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1[nH]cnc1CN1CCc2c(c3ccccc3n2C)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 122852-42-0 |
| RxCUI | 85248 |
| ChEMBL ID | CHEMBL1110 |
| ChEBI ID | 253342 |
| PubChem CID | 2099 |
| DrugBank | DB00969 |
| UNII ID | 13Z9HTH115 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
HTR3A
HTR3A
Organism
Homo sapiens
Gene name
HTR3A
Gene synonyms
5HT3R, HTR3
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 3A
Protein synonyms
5-HT-3, 5-HT3R, 5-hydroxytryptamine (serotonin) receptor 3A, ionotropic, 5-hydroxytryptamine receptor 3, 5HT3 serotonin receptor, Serotonin receptor 3A, Serotonin-gated ion channel receptor
Uniprot ID
Mouse ortholog
Htr3a (15561)
5-hydroxytryptamine receptor 3A (Q61226)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 967 documents
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Safety
Black-box Warning
Black-box warning for: Alosetron hydrochloride, Lotronex
Adverse Events
Top Adverse Reactions
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3,125 adverse events reported
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