Dexamethasone
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1958
- First approval year
- 1958
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Dexamethasone
- Molecular weight
- 392.47
- Structure (SMILES)
- C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CO
- aeroseb dex
- Aeroseb-dex
- decaderm
- Decaderm
- decadron
- Decadron
- decadron 75
- Decadron-75
- decaspray
- Decaspray
- dexa sine
- Dexa-sine
- dexacortal
- Dexacortal
- dexacortin
- Dexacortin
- dexacortisyl
- Dexacortisyl
- dexafree
- Dexafree
- dexamethasone
- Dexamethasone
- dexamethasone component of ciprodex
- Dexamethasone component of ciprodex
- dexamethasone component of dexacidin
And 71 more, listed on the interactive page.
- 16 alpha methyl 9 alpha fluoroprednisolone
- 16.ALPHA.-METHYL-9.ALPHA.-FLUOROPREDNISOLONE
- aphthasolone
- APHTHASOLONE
- BETAMETHASONE IMPURITY A [EP IMPURITY]
- betamethasone impurity a ep impurity
- ciprodex component dexamethasone
- CIPRODEX COMPONENT DEXAMETHASONE
- dexacidin component dexamethasone
- DEXACIDIN COMPONENT DEXAMETHASONE
- dexacortal
- dexametasona
- Dexametasona
- dexametasone
- Dexametasone
- DEXAMETASONE
- dexamethasone
- Dexamethasone
- DEXAMETHASONE [EMA EPAR]
- DEXAMETHASONE [EP MONOGRAPH]
- DEXAMETHASONE [GREEN BOOK]
- DEXAMETHASONE [HSDB]
- dexamethasone [INN]
- DEXAMETHASONE [JAN]
- DEXAMETHASONE [MART.]
And 80 more, listed on the interactive page.
- CAS registry numbers
- 50-02-2
- ChEMBL ID
- CHEMBL384467
- InChIKey
- UREBDLICKHMUKA-CXSFZGCWSA-N
- PubChem compound IDs
- 5743
- FDA ingredient codes (UNII)
- 7S5I7G3JQL
- A01AC02
- C05AA09
- D07AB19
- D07XB05
- D10AA03
- H02AB02
- R01AD03
- S01BA01
- S01CB01
- S02BA06
- S03BA01
Sources for recorded values
- 3264
- 22690
- Applicant
- HARROW EYE
- Approval date
- 20 Jun 1962
- Application number
- NDA013422
- Status
- Authorised
- Status date
- 26 Jul 2010
- Authorisation date
- 26 Jul 2010
- Approved indications
- Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO). Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis. Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
- Product number
- EMEA/H/C/001140
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Macular Edema
- Uveitis
European medicines record
- Patents
- 12
- Designations
- 2
- Earliest recorded loss of exclusivity
- 26 Apr 2041
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- dexamethasone
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- topical
- Action
- Agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
- Gene symbol
- NR3C1
- Protein identifier
- P04150
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Agonist
- Action type
- Agonist
- Target
- Mineralocorticoid receptor
- Gene symbol
- NR3C2
- Protein identifier
- P08235
- Median affinity
- 9
- Affinity units
- pIC50
- Mechanism
- Glucocorticoid receptor agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
- Protein identifier
- P04150
Open Targets mechanisms
- Mechanism
- Glucocorticoid receptor agonist
- Action type
- Agonist
- Target
- Glucocorticoid receptor
DrugCentral mechanisms
- Action type
- Agonist
- Gene symbol
- NR3C1
- Protein identifier
- P04150
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Leukemia, Erythroblastic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000218
- Subject identifier
- D004915
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Monocytic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000221
- Subject identifier
- D007948
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Leukemia, Myelomonocytic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000223
- Subject identifier
- D015479
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Paget Disease, Extramammary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000512
- Subject identifier
- D010145
And 292 more, listed on the interactive page.
- Condition identifier
- EFO_0000094
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000096
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000196
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000200
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000274
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000330
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000365
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000373
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000540
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 4
- Condition identifier
- EFO_0000546
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000565
- Condition identifier
- EFO_0000574
- Condition identifier
- EFO_0000613
- Highest recorded phase
- 2
And 648 more, listed on the interactive page.
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,065
- Reporting signal score
- 2,274.18
- Event
- cytomegalovirus infection
- Reports
- 1,894
- Reporting signal score
- 2,537.27
- Event
- febrile bone marrow aplasia
- Reports
- 426
- Reporting signal score
- 853.202
- Event
- febrile neutropenia
- Reports
- 4,619
- Reporting signal score
- 4,201.94
- Event
- glossodynia
- Reports
- 2,021
- Reporting signal score
- 3,340.83
- Event
- hand deformity
- Reports
- 1,687
- Reporting signal score
- 3,152.42
- Event
- neuropathy peripheral
- Reports
- 1,660
- Reporting signal score
- 1,302.42
- Event
- neutropenia
- Reports
- 5,239
- Reporting signal score
- 2,222.46
- Event
- pemphigus
- Reports
- 2,586
- Reporting signal score
- 5,677.35
- Event
- plasma cell myeloma
- Reports
- 1,664
- Reporting signal score
- 2,869.37
- Event
- pneumocystis jirovecii pneumonia
- Reports
- 1,459
- Reporting signal score
- 2,401.86
- Event
- rheumatoid arthritis
- Reports
- 4,018
- Reporting signal score
- 2,380.29
- Event
- systemic lupus erythematosus
- Reports
- 2,571
- Reporting signal score
- 3,557.44
- Event
- thrombocytopenia
- Reports
- 2,318
- Reporting signal score
- 1,685.53
- NCT00000563
- NCT00004778
- NCT00005777
- NCT04327401
- NCT00000658
- NCT00250718
- NCT00283985
- NCT00324467
- NCT00384553
- NCT00413959
- NCT00491127
- NCT00504751
- NCT01133158
- NCT01592370
- NCT01900509
- NCT02371161
- NCT02703272
- NCT02955823
- NCT03114865
- NCT03465540
- NCT03535753
- NCT03623087
- NCT03892421
- NCT05688475
- NCT05991388
And 1,117 more, listed on the interactive page.
- Dose
- 0.5-9 mg/day, 1-6 mg/kg, 10 mg, 4-8 mg, 200 mg, 80 mg, 4 mg, 2-4 mg, 0.8-1 mg, 1-2 mg, 0.4-1 mg
- Route
- Intravenous, intramuscular
- How often
- Every 6 hours to as needed, every 12 hours, every 2 to 6 hours, every 6 hours, once every 3 to 5 days, once every 2 to 3 weeks, as needed
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 3
- Polar surface area
- 94.83
- Calculated partition coefficient (ALogP)
- 1.9
- Calculated partition coefficient (XLogP)
- 1.9
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 2
- Heavy atoms
- 28
- Molecular formula
- C22H29FO5
- Monoisotopic mass
- 392.19990218
- Natural product
- No
- 0023-3348
- 0054-3176
- 0054-3177
- 0054-4179
- 0054-4180
- 0054-4181
- 0054-4182
- 0054-4183
- 0054-4184
- 0054-4186
- 0054-8174
- 0054-8175
- 0054-8176
- 0054-8179
- 0054-8180
- 0054-8181
- 0054-8183
- 0078-0771
- 0078-0876
- 0574-4031
- 0781-6186
- 0832-1430
- 0904-7266
- 0904-7267
- 0904-7444
And 183 more, listed on the interactive page.
- Recorded assays
- 7,735
- Active assays
- 439
- Confirmatory
- Other
- Screening
- Summary
- Anti-Inflammatory Agents
- Antiemetics
- Glucocorticoids
- Antineoplastic Agents, Hormonal
These details could not be displayed.
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- A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
- A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
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Approved for (74)
- Acne
- Adrenal gland disorder
- Adrenal gland hyperfunction
- Allergic rhinitis
- Ankylosing spondylitis
- Aplastic anemia
- Asthma
- Atopic conjunctivitis
- Atopic eczema
- Autoimmune thrombocytopenic purpura
- Bursitis
- Cancer
- Chorioretinitis
- Choroiditis
- Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- Congenital adrenal hyperplasia
- Contact dermatitis
- Crohn disease
- Cystoid macular edema
- Dermatitis
In development for (213)
- Acute erythroid leukemia Phase 3
- Acute leukemia of ambiguous lineage Phase 3
- Acute lymphoblastic leukemia Phase 3
- Acute megakaryoblastic leukemia Phase 3
- Acute monocytic leukemia Phase 3
- Acute myeloblastic leukemia without maturation Phase 3
- Acute myeloid leukemia Phase 3
- Acute myelomonocytic leukemia M4 Phase 3
- Acute respiratory distress syndrome Phase 3
- Adrenocortical insufficiency Phase 1
- Adult acute respiratory distress syndrome Phase 3
- Adult T-cell leukemia/lymphoma Phase 2
- Age-related macular degeneration Phase 2
- AL amyloidosis Phase 3
- Alcohol dependence Early phase 1
- Allergic disease Phase 3
- Amyloidosis Phase 3
- Anaphylaxis Phase 1
- Anaplastic large cell lymphoma Phase 2
- Anemia Phase 3
Other linked conditions (9)
- Adult glioblastoma
- Bell's palsy
- Colonic neoplasm
- Female infertility
- Interstitial lung disease
- Meralgia paresthetica
- Newborn respiratory distress syndrome
- Post-traumatic stress disorder
- Type 2 diabetes mellitus
Targets (1)
- NR3C1 Glucocorticoid receptor agonist