Precedex, Dexdor(dexmedetomidine)
Dexdor, Igalmi, Precedex (dexmedetomidine) is a small molecule pharmaceutical. Dexmedetomidine was first approved as Precedex on 1999-12-17. It is used to treat pain and psychomotor agitation in the USA. It has been approved in Europe to treat conscious sedation and premedication. It is known to target alpha-2A adrenergic receptor, alpha-2B adrenergic receptor, and alpha-2C adrenergic receptor.
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Commercial
Trade Name
FDA
EMA
Igalmi, Precedex (generic drugs available since 2014-08-18)
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 |
|---|---|---|
| dexmedetomidine hydrochloride | ANDA | 2023-06-07 |
| igalmi | New Drug Application | 2022-04-20 |
| precedex | New Drug Application | 2023-02-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
| psychomotor agitation | — | D011595 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE, PRECEDEX, HOSPIRA | |||
| 2025-12-16 | NPP | ||
DEXMEDETOMIDINE HYDROCHLORIDE, IGALMI, BIOXCEL | |||
| 2025-04-05 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Igalmi, Bioxcel | |||
| 10792246 | 2039-06-26 | DP | U-3350 |
| 11478422 | 2039-06-26 | DP | |
| 11497711 | 2039-06-26 | DP | |
| 11517524 | 2039-06-26 | DP | |
| Dexmedetomidine Hydrochloride, Dexmedetomidine Hydrochloride, Hq Spclt Pharma | |||
| 9649296 | 2036-04-20 | DP | |
| 9717796 | 2036-04-20 | DP | |
| Dexmedetomidine Hydrochloride, Precedex, Hospira | |||
| 8242158 | 2032-01-04 | DP | |
| 8338470 | 2032-01-04 | DP | |
| 8455527 | 2032-01-04 | U-421 | |
| 8648106 | 2032-01-04 | DP | |
| 9320712 | 2032-01-04 | DP | |
| 9616049 | 2032-01-04 | DP | |
| 10016396 | 2032-01-04 | DP | |
HCPCS
No data
Clinical
Clinical Trials
1202 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Delirium | D003693 | R41.0 | 4 | 10 | 11 | 35 | 19 | 76 | |
| Postoperative pain | D010149 | G89.18 | 4 | 16 | 10 | 24 | 29 | 75 | |
| Anesthesia | D000758 | 7 | 8 | 15 | 21 | 27 | 74 | ||
| Analgesia | D000698 | 1 | 4 | 8 | 12 | 16 | 38 | ||
| Pain | D010146 | EFO_0003843 | R52 | 2 | 5 | 4 | 12 | 9 | 31 |
| Emergence delirium | D000071257 | 5 | 2 | 3 | 6 | 4 | 18 | ||
| Acute pain | D059787 | R52 | 1 | 3 | 2 | 4 | 7 | 14 | |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 3 | 4 | 5 | 3 | 1 | 13 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | 1 | 1 | 2 | 2 | 7 | 12 | |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | 3 | 3 | 6 | 1 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | 1 | 4 | 2 | — | 2 | 7 |
| Tetralogy of fallot | D013771 | Q21.3 | 3 | 2 | 1 | — | — | 5 | |
| Pain management | D059408 | — | 2 | 3 | — | 1 | 4 | ||
| Tonsillectomy | D014068 | — | — | 3 | — | 1 | 4 | ||
| Sleep initiation and maintenance disorders | D007319 | F51.01 | 1 | 1 | 1 | — | 2 | 4 | |
| Cholecystectomy | D002763 | — | — | 1 | — | 3 | 4 | ||
| Cardiopulmonary bypass | D002315 | — | 2 | 2 | — | 2 | 4 | ||
| General anesthesia | D000768 | — | — | 2 | — | 1 | 3 | ||
| Laparoscopy | D010535 | — | — | 1 | — | 2 | 3 | ||
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | 1 | 2 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | 1 | 1 | — | — | 1 | 3 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | 1 | 1 | — | — | 1 | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | — | — | 1 | 2 |
| Autism spectrum disorder | D000067877 | F84.0 | — | 1 | — | — | 1 | 2 | |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | 1 | — | — | 1 | 2 |
| Burns | D002056 | T30.0 | 1 | 2 | — | — | — | 2 | |
| Ventricular heart septal defects | D006345 | Q21.0 | 1 | 1 | — | — | — | 2 | |
| Critical care | D003422 | — | 1 | — | — | 1 | 2 | ||
| Labor pain | D048949 | — | 1 | — | — | 1 | 2 | ||
| Pheochromocytoma | D010673 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amnesia | D000647 | EFO_1001454 | F44.0 | 2 | — | — | — | 1 | 3 |
| Laparoscopic cholecystectomy | D017081 | 1 | — | — | — | 1 | 2 | ||
| Hypoplastic left heart syndrome | D018636 | Q23.4 | 2 | — | — | — | — | 2 | |
| Emotions | D004644 | 1 | — | — | — | — | 1 | ||
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | — | 1 |
| Vital signs | D055986 | EFO_0004303 | 1 | — | — | — | — | 1 | |
| Vasodilation | D014664 | 1 | — | — | — | — | 1 | ||
| Vasoconstriction | D014661 | 1 | — | — | — | — | 1 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nociceptive pain | D059226 | — | — | — | — | 4 | 4 | ||
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 4 | 4 |
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | — | 2 | 2 | |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 2 | 2 |
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 2 | 2 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 2 | 2 |
| Bariatric surgery | D050110 | — | — | — | — | 1 | 1 | ||
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Nephrectomy | D009392 | — | — | — | — | 1 | 1 |
Show 72 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DEXMEDETOMIDINE |
| INN | dexmedetomidine |
| Description | Dexmedetomidine is a medetomidine. It has a role as an alpha-adrenergic agonist, a non-narcotic analgesic, an analgesic and a sedative. It is an enantiomer of a levomedetomidine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cccc([C@H](C)c2c[nH]cn2)c1C |
Identifiers
| PDB | — |
| CAS-ID | 113775-47-6 |
| RxCUI | 48937 |
| ChEMBL ID | CHEMBL778 |
| ChEBI ID | 4466 |
| PubChem CID | 5311068 |
| DrugBank | DB00633 |
| UNII ID | 67VB76HONO (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ADRA2A
ADRA2A
ADRA2B
ADRA2B
ADRA2C
ADRA2C
Organism
Homo sapiens
Gene name
ADRA2A
Gene synonyms
ADRA2R, ADRAR
NCBI Gene ID
Protein name
alpha-2A adrenergic receptor
Protein synonyms
adrenergic, alpha-2A-, receptor, Alpha-2 adrenergic receptor subtype C10, alpha-2-adrenergic receptor, platelet type, Alpha-2A adrenoceptor, Alpha-2A adrenoreceptor, Alpha-2AAR, alpha-2AAR subtype C10
Uniprot ID
Mouse ortholog
Adra2a (11551)
alpha-2A adrenergic receptor (Q3URE6)
Variants
Clinical Variant
No data
Financial
Precedex - Pfizer
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,414 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,378 adverse events reported
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