Deutetrabenazine
Austedo, Deutetrabenazine (deutetrabenazine) is a small molecule pharmaceutical. Deutetrabenazine was first approved as Austedo on 2017-04-03. It is used to treat chorea and tardive dyskinesia in the USA.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Austedo (discontinued: Deutetrabenazine)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| austedo | New Drug Application | 2022-05-17 |
| austedo austedo xr | New Drug Application | 2025-02-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| tardive dyskinesia | — | D000071057 | G24.01 |
| chorea | EFO_0004152 | D002819 | G25.5 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DEUTETRABENAZINE, AUSTEDO, TEVA BRANDED PHARM | |||
| 2024-12-24 | PED | ||
| 2024-10-03 | PED | ||
| 2024-06-24 | M-54 | ||
| 2024-04-03 | ODE-134 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Deutetrabenazine, Austedo Xr, Teva | |||
| 11311488 | 2041-06-10 | DP | U-1995, U-3055 |
| Deutetrabenazine, Austedo, Teva Branded Pharm | |||
| 11179386 | 2038-03-15 | DP | U-1995, U-3055 |
| 11813232 | 2038-03-15 | DP | |
| 10959996 | 2036-03-07 | U-3055 | |
| 11357772 | 2036-03-07 | U-1995, U-3055 | |
| 11446291 | 2036-03-07 | U-1995 | |
| 11564917 | 2036-03-07 | U-1995 | |
| 11648244 | 2036-03-07 | U-1995 | |
| 9233959 | 2033-09-18 | DP | |
| 9296739 | 2033-09-18 | DP | |
| 9550780 | 2033-09-18 | DS, DP | U-1995, U-3055 |
| 9814708 | 2033-09-18 | DP | |
| 11666566 | 2033-09-18 | DP | |
| 8524733 | 2031-04-03 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | — | — | 1 | — | 1 |
| Tardive dyskinesia | D000071057 | — | G24.01 | — | — | — | 1 | — | 1 |
| Movement disorders | D009069 | EFO_0004280 | G25 | — | — | — | 1 | — | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | 1 | — | 1 |
| Caregiver burden | D000084802 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | 1 | 3 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | 3 | — | — | 3 |
| Huntington disease | D006816 | Orphanet_399 | G10 | — | 1 | 2 | — | — | 2 |
| Cerebral palsy | D002547 | — | G80 | — | — | 2 | — | — | 2 |
| Chorea | D002819 | EFO_0004152 | G25.5 | — | — | 1 | — | — | 1 |
| Dyskinesias | D020820 | — | G24 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dystonic disorders | D020821 | — | G24 | 1 | 1 | — | — | — | 1 |
| Dystonia | D004421 | — | — | 1 | 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 | Deutetrabenazine |
| INN | deutetrabenazine |
| Description | Austedo (dutetrabenazine) is a small molecule pharmaceutical. Dutetrabenazine was first approved as Austedo on 2017-04-03. |
| Classification | Small molecule |
| Drug class | deuterated compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | [2H]C([2H])([2H])Oc1cc2c(cc1OC([2H])([2H])[2H])C1CC(=O)C(CC(C)C)CN1CC2 |
Identifiers
| PDB | — |
| CAS-ID | 1392826-25-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3137326 |
| ChEBI ID | — |
| PubChem CID | 45255840 |
| DrugBank | DB12161 |
| UNII ID | P341G6W9NB (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
Revenue by drug
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Austedo – Teva
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Estimated US medical usage
No data
Trends
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Safety
Black-box Warning
Black-box warning for: Austedo, Austedo austedo xr
Adverse Events
Top Adverse Reactions
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5,652 adverse events reported
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