Tapentadol
Nucynta (tapentadol) is a small molecule pharmaceutical. Tapentadol was first approved as Nucynta on 2008-11-20. It is used to treat pain in the USA. The pharmaceutical is active against sodium-dependent noradrenaline transporter and mu-type opioid receptor.
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Commercial
Trade Name
FDA
EMA
Nucynta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nucynta | New Drug Application | 2021-11-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tapentadol Hydrochloride, Nucynta Er, Collegium Pharm Inc | |||
| 8536130 | 2028-09-22 | U-1276 | |
| 11344512 | 2028-04-21 | U-3391, U-3392 | |
| 8114383 | 2024-10-10 | DP | |
| 8075872 | 2023-11-20 | DP | |
| 8309060 | 2023-11-20 | DP | U-1178, U-1276 |
| 8420056 | 2023-11-20 | DP | |
| Tapentadol Hydrochloride, Nucynta, Collegium Pharm Inc | |||
| 7994364 | 2025-06-27 | DS, DP | U-931, U-1178, U-1276, U-1289 |
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | 2 | 1 | 1 | 1 | 5 |
| Pharyngitis | D010612 | R07.0 | — | — | 2 | 1 | — | 3 | |
| Postoperative pain | D010149 | G89.18 | — | — | — | 1 | 1 | 2 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Toothache | D014098 | K08.89 | — | — | — | 1 | — | 1 | |
| Dental pins | D003772 | — | — | — | 1 | — | 1 | ||
| Dry eye syndromes | D015352 | H04.12 | — | — | — | 1 | — | 1 | |
| Analgesia | D000698 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | 1 | — | — | 1 | ||
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | 1 | — | — | 1 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | — | — | 1 | |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | 1 | — | — | 1 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | 1 | — | — | 1 |
| Abdominal pain | D015746 | R10.9 | — | — | 1 | — | — | 1 | |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | — | 1 | — | — | 1 |
| Stomach diseases | D013272 | — | 1 | 1 | — | — | 1 | ||
| Capsule endoscopy | D053704 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Local anesthesia | D000772 | — | 1 | — | — | 2 | 3 | ||
| Critical illness | D016638 | — | 1 | — | — | — | 1 | ||
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | 1 | — | — | — | 1 |
| Dental anesthesia | D000766 | 1 | 1 | — | — | — | 1 | ||
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 1 | — | — | — | 1 |
| Gingivitis | D005891 | K05.10 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral lichen planus | D017676 | 1 | — | — | — | 2 | 3 | ||
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
| Oral ulcer | D019226 | HP_0000155 | 1 | — | — | — | — | 1 | |
| Staphylococcal infections | D013203 | A49.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
| Orthodontic anchorage procedures | D052280 | — | — | — | — | 1 | 1 | ||
| Body weight | D001835 | EFO_0004338 | — | — | — | — | 1 | 1 | |
| Glucose metabolism disorders | D044882 | — | — | — | — | 1 | 1 | ||
| Lichen planus | D008010 | L43 | — | — | — | — | 1 | 1 | |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | 1 | 1 | |
| Feeding behavior | D005247 | — | — | — | — | 1 | 1 | ||
| Duchenne muscular dystrophy | D020388 | — | — | — | — | 1 | 1 | ||
| Scoliosis | D012600 | EFO_0004273 | M41 | — | — | — | — | 1 | 1 |
| Lordosis | D008141 | M40.5 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TAPENTADOL |
| INN | tapentadol |
| Description | Tapentadol is an alkylbenzene. |
| Classification | Small molecule |
| Drug class | analgesics (mixed opiate receptor agonists/antagonists) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C |
Identifiers
| PDB | — |
| CAS-ID | 175591-09-0 |
| RxCUI | 787390 |
| ChEMBL ID | CHEMBL1201776 |
| ChEBI ID | — |
| PubChem CID | 9838022 |
| DrugBank | DB06204 |
| UNII ID | H8A007M585 (ChemIDplus, GSRS) |
Target
Agency Approved
SLC6A2
SLC6A2
OPRM1
OPRM1
Organism
Homo sapiens
Gene name
SLC6A2
Gene synonyms
NAT1, NET1, SLC6A5
NCBI Gene ID
Protein name
sodium-dependent noradrenaline transporter
Protein synonyms
NET, neurotransmitter transporter, Norepinephrine transporter, solute carrier family 6 (neurotransmitter transporter), member 2, solute carrier family 6 (neurotransmitter transporter, noradrenalin), member 2, Solute carrier family 6 member 2, solute carrier family 6 member 5
Uniprot ID
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nucynta - Assertio Therapeutics
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Nucynta - Assertio Therapeutics
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Nucynta - Collegium Pharmaceutical
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Trends
PubMed Central
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Additional graphs summarizing 1,986 documents
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Safety
Black-box Warning
Black-box warning for: Nucynta
Adverse Events
Top Adverse Reactions
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11 adverse events reported
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