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
Dexmedetomidine, Igalmi, Precedex (discontinued: Dexmedetomidine)
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 | 2024-07-09 |
| dexmedetomidine dexmedetomidine hydrochloride | ANDA | 2023-06-01 |
| dexmedetomidine hcl | ANDA | 2023-05-04 |
| dexmedetomidine hydrochloride | ANDA | 2024-09-26 |
| dexmedetomidine hydrochloride dexmedetomidine hydrochloride in dextrose | New Drug Application | 2021-12-31 |
| dexmedetomidine hydrochloride in 0.9% sodium chloride | ANDA | 2023-10-06 |
| dexmedetomidine hydrochloride in sodium chloride | ANDA | 2023-12-21 |
| igalmi | New Drug Application | 2022-12-14 |
| precedex | New Drug Application | 2024-10-22 |
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 | 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
1700 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 | 6 | 25 | 22 | 43 | 81 | 164 |
| Delirium | D003693 | — | R41.0 | 8 | 14 | 17 | 55 | 47 | 136 |
| Anesthesia | D000758 | — | — | 7 | 8 | 20 | 30 | 45 | 106 |
| Emergence delirium | D000071257 | — | — | 13 | 9 | 13 | 35 | 36 | 99 |
| Analgesia | D000698 | — | — | 1 | 4 | 9 | 18 | 27 | 56 |
| Psychomotor agitation | D011595 | — | — | 7 | 11 | 13 | 13 | 10 | 49 |
| Pain | D010146 | EFO_0003843 | R52 | 4 | 6 | 4 | 16 | 18 | 47 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 1 | 1 | 15 | 10 | 27 |
| Critical illness | D016638 | — | — | 2 | 1 | 6 | 11 | 7 | 26 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 1 | 3 | 4 | 7 | 12 | 25 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hernia | D006547 | HP_0100790 | K40-K46 | 1 | — | 1 | — | 5 | 7 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 2 | 1 | — | 3 | 6 |
| Laparoscopy | D010535 | — | — | — | 1 | 2 | — | 4 | 6 |
| Cholecystectomy | D002763 | — | — | — | — | 2 | — | 4 | 6 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | 1 | 1 | — | 2 | 6 |
| Traumatic stress disorders | D040921 | — | — | 2 | 1 | 1 | — | 2 | 6 |
| Pain management | D059408 | — | — | — | 2 | 3 | — | 2 | 5 |
| Colorectal neoplasms | D015179 | — | — | — | — | 1 | — | 4 | 5 |
| Post-dural puncture headache | D051299 | — | — | 1 | — | 1 | — | 3 | 5 |
| Dementia | D003704 | EFO_0003862 | F03 | 1 | 3 | 2 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | 1 | 2 | — | — | 1 | 4 |
| Pheochromocytoma | D010673 | — | — | — | 1 | — | — | 2 | 3 |
| Burns | D002056 | — | T30.0 | 1 | 2 | — | — | 1 | 3 |
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | 1 | 1 | — | — | 1 | 3 |
| Hematoma | D006406 | EFO_0010680 | — | 1 | 1 | — | — | 2 | 3 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 2 | — | — | 1 | 3 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | 2 | — | — | 1 | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | — | — | 1 | 2 |
| Intraoperative awareness | D058926 | — | — | — | 1 | — | — | 1 | 2 |
| Hyperalgesia | D006930 | — | — | — | 1 | — | — | 1 | 2 |
Show 33 more
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 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | — | — | — | — | 2 |
| Gastric emptying | D005746 | — | — | 1 | — | — | — | 1 | 2 |
| Hypoplastic left heart syndrome | D018636 | — | Q23.4 | 2 | — | — | — | — | 2 |
| Memory disorders | D008569 | — | — | 1 | — | — | — | 1 | 2 |
| Emotions | D004644 | — | — | 1 | — | — | — | — | 1 |
| Vital signs | D055986 | EFO_0004303 | — | 1 | — | — | — | — | 1 |
| Vasodilation | D014664 | — | — | 1 | — | — | — | — | 1 |
| Vasoconstriction | D014661 | — | — | 1 | — | — | — | — | 1 |
| Cerebrospinal fluid pressure | D015170 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 5 | 5 |
| Nociceptive pain | D059226 | — | — | — | — | — | — | 4 | 4 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 3 | 3 |
| Morphine dependence | D009021 | EFO_0005612 | — | — | — | — | — | 3 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 2 | 2 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 2 | 2 |
| Hypokalemia | D007008 | HP_0002900 | E87.6 | — | — | — | — | 2 | 2 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 2 | 2 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | — | — | — | 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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3,185 adverse events reported
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