Hyoscyamine
Hyoscyamine is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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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 |
|---|---|---|
| anaspaz | unapproved drug other | 2024-07-25 |
| atropine | ANDA | 2024-10-16 |
| atropine care | unapproved drug other | 2011-01-06 |
| atropine sulfate | ANDA | 2025-06-16 |
| diphenoxylate hcl and atropine sulfate | ANDA | 2010-03-24 |
| diphenoxylate hydrochloride and atropine sulfate | ANDA | 2025-06-12 |
| 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 |
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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
372 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | EFO_0003927 | H52.1 | 11 | 13 | 17 | 10 | 28 | 73 |
| Neuromuscular blockade | D019148 | — | — | 1 | 3 | 3 | 12 | 5 | 23 |
| Anesthesia | D000758 | — | — | — | — | 3 | 2 | 8 | 13 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | 2 | 8 | 11 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | 2 | 2 | 2 | 2 | 4 | 11 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 3 | 7 | 10 |
| Vomiting | D014839 | — | R11.1 | — | — | 1 | 3 | 6 | 10 |
| Bradycardia | D001919 | — | R00.1 | — | 1 | — | 5 | 4 | 10 |
| Nausea | D009325 | — | R11.0 | — | — | 1 | 3 | 5 | 9 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 1 | 2 | 6 | 9 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Degenerative myopia | D047728 | — | H44.2 | 2 | 3 | 4 | — | 5 | 12 |
| General anesthesia | D000768 | — | — | — | 2 | 2 | — | 3 | 7 |
| Emergence delirium | D000071257 | — | — | — | 1 | 1 | — | 3 | 4 |
| Delirium | D003693 | — | R41.0 | — | 1 | 1 | — | 2 | 3 |
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | 1 | — | — | 3 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | — | 1 | — | 1 | 2 |
| Premedication | D011292 | — | — | — | 2 | 2 | — | — | 2 |
| Replacement arthroplasty hip | D019644 | — | — | — | — | 1 | — | 1 | 2 |
| Chest pain | D002637 | — | R07.9 | — | — | 1 | — | 1 | 2 |
| Anisometropia | D015858 | — | H52.31 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | 2 | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | 1 | 2 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 2 | — | — | — | 2 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 1 | — | — | — | 2 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | 1 | 1 | — | — | — | 2 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | 1 | — | — | 1 | 2 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 2 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 1 | — | — | — | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | 1 | 2 |
| Hypoglycemia | D007003 | — | E16.2 | 2 | — | — | — | — | 2 |
| Sialorrhea | D012798 | — | K11.7 | 1 | — | — | — | 1 | 2 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | 1 | 2 |
| Death | D003643 | PATO_0001422 | — | 1 | — | — | — | 1 | 2 |
| Digestive system physiological phenomena | D004068 | — | — | 1 | — | — | — | — | 1 |
| Gastrointestinal motility | D005769 | — | — | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 4 | 4 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 3 | 3 |
| Analgesia | D000698 | — | — | — | — | — | — | 3 | 3 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 2 | 2 |
| Conduction anesthesia | D000765 | — | — | — | — | — | — | 2 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 2 | 2 |
| Psychomotor agitation | D011595 | — | — | — | — | — | — | 2 | 2 |
| Hernia | D006547 | — | K40-K46 | — | — | — | — | 2 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 2 | 2 |
| Intravenous anesthesia | D000771 | — | — | — | — | — | — | 2 | 2 |
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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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Financial
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Estimated US medical usage
Hyoscyamine
+
Phenazopyridine
+
Butabarbital
Total medical expenditures per year (USD, in millions)
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Hyoscyamine
Total medical expenditures per year (USD, in millions)
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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7,303 adverse events reported
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