Diphenoxylate
Atropine / Diphenoxylate, Lomotil (diphenoxylate) is a small molecule pharmaceutical. Diphenoxylate was first approved as Lomotil on 1982-01-01. It is used to treat diarrhea in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Diphenoxylate atropine, Lomotil (discontinued: Colonaid, Diphenoxylate atropine, Diphenoxylate w/ atropine, Logen, Lomanate, Lomotil, Lonox, Low-quel)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diphenoxylate hcl and atropine sulfate | ANDA | 2010-03-24 |
| diphenoxylate hydrochloride and atropine sulfate | ANDA | 2025-08-05 |
| direct rx | NDA authorized generic | 2015-08-05 |
| lomotil | New Drug Application | 2025-04-03 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | 1 | — | — | 3 |
| Short bowel syndrome | D012778 | — | K90.82 | — | — | 2 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 1 | — | — | 1 |
| Vomiting | D014839 | — | R11.1 | — | — | 1 | — | — | 1 |
| Nausea | D009325 | — | R11.0 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | — | 1 | — | — | 1 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 2 |
| Alveolar soft part sarcoma | D018234 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 1 | — | — | — | 1 |
| Granulosa cell tumor | D006106 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Diphenoxylate |
| INN | diphenoxylate |
| Description | Diphenoxylate is a piperidinecarboxylate ester that is the ethyl ester of difenoxin. It has a role as an antidiarrhoeal drug. It is a nitrile, a piperidinecarboxylate ester, a tertiary amine and an ethyl ester. It is functionally related to a difenoxin. |
| Classification | Small molecule |
| Drug class | Opioid Antidiarrheal |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)C1(c2ccccc2)CCN(CCC(C#N)(c2ccccc2)c2ccccc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 915-30-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201294 |
| ChEBI ID | 4639 |
| PubChem CID | 13505 |
| DrugBank | DB01081 |
| UNII ID | 73312P173G (ChemIDplus, GSRS) |
Target
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Variants
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Estimated US medical usage
Diphenoxylate
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Atropine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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2,235 adverse events reported
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