Sepiapterin
Sephience (sepiapterin) is a small molecule pharmaceutical. Sepiapterin was first approved as Sephience on 2025-07-28.
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FDA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
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Sephience
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sepiapterin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SEPHIENCE | PTC Therapeutics | N-219666 RX | 2025-07-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sephience | New Drug Application | 2025-10-02 |
Indications
FDA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
5 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 |
|---|---|---|---|---|---|---|---|---|---|
| Phenylketonurias | D010661 | — | E70.0 | 1 | 1 | 3 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 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 | Sepiapterin |
| INN | sepiapterin |
| Description | Sepiapterin, sold under the brand name Sephience, is a medication used for the treatment of hyperphenylalaninemia. Sepiapterin is a phenylalanine hydroxylase activator.
|
| Classification | Small molecule |
| Drug class | aptamers, classical and mirror; pteridine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](O)C(=O)C1=Nc2c(nc(N)[nH]c2=O)NC1 |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1255653 |
| ChEBI ID | — |
| PubChem CID | 65253 |
| DrugBank | — |
| UNII ID | CJQ26KO7HP (ChemIDplus, GSRS) |
Target
No data
Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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