Hyoscyamine
Hyoscyamine is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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FDA approval date
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Commercial
Therapeutic Areas
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Trade Name
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atropine | ANDA | 2025-09-29 |
| atropine care | unapproved drug other | 2011-01-06 |
| atropine sulfate | ANDA | 2025-10-02 |
| 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 |
| donnatal | unapproved drug other | 2024-12-05 |
| donnatal extentabs | unapproved drug other | 2011-10-17 |
| gabapentin | ANDA | 2017-05-11 |
| hyophen | unapproved drug other | 2017-01-05 |
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Indications
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Agency Specific
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Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A03: Drugs for functional gastrointestinal disorders
— A03B: Belladonna and derivatives containing drugs, plain for functional gastrointestinal disorders
— A03BA: Belladonna alkaloids, tertiary amines for functional gastrointestinal disorders
— A03BA03: Hyoscyamine
— A03C: Antispasmodics in combination with psycholeptics
— A03CB: Belladonna and derivatives in combination with psycholeptics
— A03CB31: Hyoscyamine and psycholeptics
HCPCS
Code | Description |
|---|---|
| J1980 | Injection, hyoscyamine sulfate, up to 0.25 mg |
Clinical
Clinical Trials
470 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 2 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hyoscyamine |
| INN | — |
| Description | (S)-atropine is an atropine with a 2S-configuration. It is functionally related to a (S)-tropic acid. It is a conjugate base of a (S)-atropinium. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1[C@H]2CC[C@@H]1C[C@H](OC(=O)[C@H](CO)c1ccccc1)C2 |
Identifiers
| PDB | — |
| CAS-ID | 101-31-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1331216 |
| ChEBI ID | 17486 |
| PubChem CID | 154417 |
| DrugBank | DB00424 |
| UNII ID | — |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Hyoscyamine
+
Phenazopyridine
+
Butabarbital
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Price per prescription (USD)
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Hyoscyamine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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922 adverse events reported
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