Precedex, Dexdor(dexmedetomidine)
Dexdor, Dexmedetomidine, 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.
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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)
Dexmedetomidine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IGALMI | Bioxcel Therapeutics | N-215390 RX | 2022-04-05 | 2 products, RLD, RS |
| PRECEDEX | Hospira | N-021038 RX | 1999-12-17 | 5 products, RLD, RS |
| DEXMEDETOMIDINE HYDROCHLORIDE | HQ Specialty Pharma | N-206628 RX | 2015-10-21 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dexmedetomidine | ANDA | 2023-12-21 |
| dexmedetomidine dexmedetomidine hydrochloride | ANDA | 2023-06-01 |
| dexmedetomidine hcl | ANDA | 2023-05-04 |
| dexmedetomidine hydrochloride | ANDA | 2023-12-27 |
| dexmedetomidine hydrochloride dexmedetomidine hydrochloride in dextrose | New Drug Application | 2021-12-31 |
| dexmedetomidine hydrochloride in 0.9% sodium chloride | ANDA | 2023-06-15 |
| dexmedetomidine hydrochloride in sodium chloride | ANDA | 2023-12-21 |
| precedex | New Drug Application | 2023-12-22 |
| precedex dexmedetomidine hci chloride | New Drug Application | 2023-02-10 |
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 | U-3645 |
| 11517524 | 2039-06-26 | DP | U-3645 |
| 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
1579 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 4 | 21 | 14 | 28 | 51 | 108 |
| Anesthesia | D000758 | — | — | 7 | 8 | 20 | 29 | 41 | 101 |
| Delirium | D003693 | — | R41.0 | 5 | 11 | 12 | 35 | 27 | 87 |
| Analgesia | D000698 | — | — | 1 | 4 | 9 | 17 | 23 | 51 |
| Pain | D010146 | EFO_0003843 | R52 | 4 | 6 | 4 | 16 | 15 | 44 |
| Emergence delirium | D000071257 | — | — | 7 | 2 | 3 | 8 | 7 | 25 |
| Acute pain | D059787 | — | R52 | 1 | 3 | 3 | 5 | 8 | 17 |
| Critical illness | D016638 | — | — | 1 | 1 | 4 | 6 | 6 | 17 |
| Spinal anesthesia | D000775 | — | — | — | 1 | 2 | 5 | 9 | 16 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 1 | 2 | 3 | 3 | 8 | 16 |
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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 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 1 | 1 | — | 3 | 5 |
| Cholecystectomy | D002763 | — | — | — | — | 2 | — | 3 | 5 |
| Cardiopulmonary bypass | D002315 | — | — | — | 2 | 2 | — | 3 | 5 |
| Tetralogy of fallot | D013771 | HP_0001636 | Q21.3 | 3 | 2 | 1 | — | — | 5 |
| Pain management | D059408 | — | — | — | 2 | 3 | — | 1 | 4 |
| Laparoscopy | D010535 | — | — | — | — | 1 | — | 3 | 4 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | 1 | — | 3 | 4 |
| Dementia | D003704 | EFO_0003862 | F03 | 1 | 2 | 2 | — | — | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | — | 2 | 4 |
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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 |
| Pheochromocytoma | D010673 | — | — | — | 1 | — | — | 1 | 2 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | — | — | 1 | 2 |
| Intraoperative awareness | D058926 | — | — | — | 1 | — | — | 1 | 2 |
| Autism spectrum disorder | D000067877 | HP_0000729 | 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 |
| Familial dysautonomia | D004402 | Orphanet_1764 | G90.1 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | 2 | 3 |
| Amnesia | D000647 | EFO_1001454 | F44.0 | 2 | — | — | — | 1 | 3 |
| 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 |
Show 14 more
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 |
| Craniotomy | D003399 | — | — | — | — | — | — | 3 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 2 | 2 |
| Hypokalemia | D007008 | HP_0002900 | E87.6 | — | — | — | — | 2 | 2 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | — | — | — | 2 | 2 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 2 | 2 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 2 | 2 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | — | — | — | 2 | 2 |
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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 | — |
| ChEMBL ID | CHEMBL778 |
| ChEBI ID | 4466 |
| PubChem CID | 5311068 |
| DrugBank | DB00633 |
| UNII ID | 67VB76HONO (ChemIDplus, GSRS) |
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Precedex – Pfizer
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Safety
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Adverse Events
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2,175 adverse events reported
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