Hexadrol, Ozurdex(dexamethasone)

Ciprodex, Decadron, Dexacen, Dexacort, Dexair, Dextenza, Dexycu, Hemady, Hexadrol, Maxidex, Maxitrol, Neofordex, Ozurdex, Tobradex (dexamethasone) is a small molecule pharmaceutical. Dexamethasone was first approved as Hexadrol on 1982-01-01. It is used to treat addison disease, allergic rhinitis perennial, ankylosing spondylitis, brain edema, and bursitis amongst others in the USA. It has been approved in Europe to treat macular edema, multiple myeloma, and uveitis. It is known to target glucocorticoid receptor and mineralocorticoid receptor.

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COVID-19

Novartis Pharmaceuticals

Case Study: COVID-19

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
musculoskeletal diseases	D009140
digestive system diseases	D004066
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
nervous system diseases	D009422
eye diseases	D005128
cardiovascular diseases	D002318
hemic and lymphatic diseases	D006425

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Trade Name

FDA

EMA

Dextenza, Dexycu, Hemady, Maxidex, Ozurdex (generic drugs available since 1982-01-01, discontinued: Aeroseb-dex, Decaderm, Decadron, Decadron-la, Decaspray, Dexacen, Dexacort, Dexair, Dexone, Hexadrol, Maxidex)

Combinations

Ciprodex, Maxitrol, Tobradex (generic drugs available since 1982-01-01, discontinued: Decadron w/ xylocaine, Dexacidin, Dexasporin, Neodecadron)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ciprofloxacin

Dexamethasone

Tradename	Company	Number	Date	Products
CIPRODEX	Novartis	N-021537 RX	2003-07-18	1 products, RLD, RS

Dexamethasone

Tradename	Company	Number	Date	Products
OZURDEX	AbbVie	N-022315 RX	2009-06-17	1 products, RLD, RS
HEMADY	Dexcel Pharma	N-211379 RX	2019-10-03	1 products, RLD, RS
DEXYCU KIT	Eyepoint Pharmaceuticals	N-208912 RX	2018-02-09	1 products, RLD, RS
MAXIDEX	Harrow	N-013422 RX	1982-01-01	1 products, RLD, RS
DEXTENZA	Ocular Therapeutix	N-208742 RX	2018-11-30	1 products, RLD, RS

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Dexamethasone

Neomycin sulfate

Polymyxin b sulfate

Tradename	Company	Number	Date	Products
MAXITROL	Harrow	N-050023 RX	1982-01-01	1 products, RLD, RS
MAXITROL	Novartis	N-050065 RX	1982-01-01	1 products, RLD, RS

Dexamethasone

Tobramycin

Tradename	Company	Number	Date	Products
TOBRADEX ST	Eyevance	N-050818 RX	2009-02-13	1 products, RLD, RS
TOBRADEX	Novartis	N-050592 RX	1988-08-18	1 products, RLD, RS
TOBRADEX	Novartis	N-050616 RX	1988-09-28	1 products, RLD, RS

Dexamethasone acetate

Tradename	Company	Number	Date	Products
DECADRON-LA	Merck KGaA	N-016675 DISCN	1982-01-01	1 products, RLD

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Dexamethasone sodium phosphate

Tradename	Company	Number	Date	Products
HEXADROL	Aspen Global	N-014694 DISCN	1982-01-01	3 products
DECADRON	Merck KGaA	N-011977 DISCN	1982-01-01	1 products
DECADRON	Merck KGaA	N-011983 DISCN	1982-01-01	1 products
DECADRON	Merck KGaA	N-011984 DISCN	1982-01-01	1 products, RLD
DECADRON	Merck KGaA	N-012071 DISCN	1982-01-01	2 products, RLD
DEXACORT	UCB	N-013413 DISCN	1982-01-01	1 products
DEXACORT	UCB	N-014242 DISCN	1982-01-01	1 products

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Dexamethasone sodium phosphate

Lidocaine hydrochloride

Tradename	Company	Number	Date	Products
DECADRON W/ XYLOCAINE	Merck KGaA	N-013334 DISCN	1982-01-01	1 products

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Dexamethasone sodium phosphate

Neomycin sulfate

Tradename	Company	Number	Date	Products
NEODECADRON	Merck KGaA	N-050322 DISCN	1982-01-01	1 products
NEODECADRON	Merck KGaA	N-050324 DISCN	1982-01-01	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
ciprodex	New Drug Application	2021-10-01
decadron	ANDA	2017-10-01
dexamethasone sodium phosphate	ANDA	2023-06-19
dextenza	New Drug Application	2020-11-02
dexycu	New Drug Application	2020-06-15
hemady	New Drug Application	2020-10-19
maxidex	New Drug Application	2023-04-20
maxitrol	New Drug Application	2022-11-10
ozurdex	New Drug Application	2020-10-30
tobradex	New Drug Application	2023-04-19

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
addison disease	—	D000224	E27.1
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
ankylosing spondylitis	EFO_0003898	D013167	M45
brain edema	EFO_1000845	D001929	G93.6
bursitis	EFO_1000941	D002062	M71.9
collagen diseases	—	D003095	—
dermatitis herpetiformis	—	D003874	L13.0
hypercalcemia	HP_0003072	D006934	E83.52
iritis	EFO_1000997	D007500	—
keratitis	—	D007634	H16

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Agency Specific

FDA

EMA

Expiration	Code
DEXAMETHASONE, HEMADY, DEXCEL
2026-10-03	ODE-271
DEXAMETHASONE, DEXTENZA, OCULAR THERAPEUTIX
2024-10-07	I-876
DEXAMETHASONE, DEXAMETHASONE, AMNEAL
2023-03-08	CGT

Patent Expiration

Patent	Expires	Flag	FDA Information
Dexamethasone, Dexycu Kit, Eyepoint Pharms
11097061	2039-06-23	DP	U-3418
10022502	2034-06-22		U-2340
10028965	2034-05-23		U-2340
10159683	2034-05-23	DP
10799642	2032-05-11	DP
6960346	2023-07-03	DP
Dexamethasone, Hemady, Dexcel
10537585	2037-12-18	DP
11304961	2037-12-18	DP	U-3344
Dexamethasone, Dextenza, Ocular Therapeutix
11458041	2037-11-16		U-1680, U-3455
8409606	2030-05-14	DP
8563027	2030-02-12		U-2487
9254267	2024-09-11	DP
Dexamethasone / Tobramycin, Tobradex St, Eyevance
7795316	2028-08-03	DP	U-1082
8101582	2027-12-19	DP	U-1082
8450287	2027-12-19	DP
Ciprofloxacin / Dexamethasone, Ciprodex, Novartis
8846650	2025-06-04	DP	U-1578
Dexamethasone, Ozurdex, Abbvie
6899717	2023-11-01		U-1206
8034366	2023-01-09	DP	U-1204, U-1205
8034370	2023-01-09	DP
8506987	2023-01-09		U-1204, U-1205
9192511	2023-01-09	DP
10076526	2023-01-09	DP
10702539	2023-01-09		U-985, U-1597, U-2868

ATC Codes

A: Alimentary tract and metabolism drugs

— A01: Stomatological preparations

— A01A: Stomatological preparations

— A01AC: Corticosteroids for local oral treatment

— A01AC02: Dexamethasone

C: Cardiovascular system drugs

— C05: Vasoprotectives

— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use

— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures

— C05AA09: Dexamethasone

D: Dermatologicals

— D07: Corticosteroids, dermatological preparations

— D07A: Corticosteroid dermatological preparations, plain

— D07AB: Corticosteroids, moderately potent (group ii)

— D07AB19: Dexamethasone

— D07C: Corticosteroids, combinations with antibiotics

— D07CB: Corticosteroids, moderately potent, combinations with antibiotics

— D07CB04: Dexamethasone and antibiotics

— D07X: Corticosteroids, other combinations

— D07XB: Corticosteroids, moderately potent, other combinations

— D07XB05: Dexamethasone

— D10: Anti-acne preparations

— D10A: Anti-acne preparations for topical use

— D10AA: Corticosteroids, combinations for treatment of acne

— D10AA03: Dexamethasone

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H02: Corticosteroids for systemic use

— H02A: Corticosteroids for systemic use, plain

— H02AB: Glucocorticoids, systemic

— H02AB02: Dexamethasone

R: Respiratory system drugs

— R01: Nasal preparations

— R01A: Decongestants and other nasal preparations for topical use

— R01AD: Corticosteroid nasal preparations for topical use

— R01AD03: Dexamethasone

— R01AD53: Dexamethasone, combinations

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01B: Antiinflammatory agents, ophthalmologic

— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain

— S01BA01: Dexamethasone

— S01C: Antiinflammatory agents and antiinfectives in combination

— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic

— S01CA01: Dexamethasone and antiinfectives

— S01CB: Corticosteroids/antiinfectives/mydriatics in combination

— S01CB01: Dexamethasone

— S02: Otologicals

— S02B: Corticosteroid otologicals

— S02BA: Corticosteroids

— S02BA06: Dexamethasone

— S02C: Corticosteroids and antiinfectives in combination, otologic

— S02CA: Corticosteroids and antiinfectives in combination

— S02CA06: Dexamethasone and antiinfectives

— S03: Ophthalmological and otological preparations

— S03B: Corticosteroid ophthalmologic and otologic preparations

— S03BA: Corticosteroids

— S03BA01: Dexamethasone

— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic

— S03CA: Corticosteroids and antiinfectives in combination

— S03CA01: Dexamethasone and antiinfectives

HCPCS

Code	Description
J1094	Injection, dexamethasone acetate, 1 mg
J1095	Injection, dexamethasone 9 percent, intraocular, 1 microgram
J1096	Dexamethasone, lacrimal ophthalmic insert, 0.1 mg
J1100	Injection, dexamethasone sodium phosphate, 1 mg
J7312	Injection, dexamethasone, intravitreal implant, 0.1 mg
J7637	Dexamethasone, inhalation solution, compounded product, administered through dme, concentrated form, per milligram
J7638	Dexamethasone, inhalation solution, compounded product, administered through dme, unit dose form, per milligram
J8540	Dexamethasone, oral, 0.25 mg

Clinical

Clinical Trials

2749 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101		C90.0	219	412	141	10	16	675
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	45	68	36	16	5	145
Postoperative pain	D010149		G89.18	5	14	18	59	28	119
Macular edema	D008269			8	27	20	26	26	98
Vomiting	D014839	HP_0002013	R11.1	4	17	37	15	13	85
Postoperative nausea and vomiting	D020250	EFO_0004888		1	11	12	32	17	70
Neoplasms	D009369		C80	23	24	17	5	3	63
Cataract	D002386	EFO_0001059	H26.9	2	5	10	17	11	44
Non-hodgkin lymphoma	D008228		C85.9	18	19	3	1	3	39
Thrombocytopenic purpura idiopathic	D016553	EFO_0007160	D69.3	—	15	16	6	1	36

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223		C85.9	13	43	17	—	3	72
Leukemia	D007938		C95	7	36	26	—	7	69
Plasma cell neoplasms	D054219			6	33	10	—	1	46
Immunoglobulin light-chain amyloidosis	D000075363			11	14	4	—	—	25
Hodgkin disease	D006689		C81	8	11	4	—	—	21
Amyloidosis	D000686	EFO_1001875	E85	7	12	2	—	4	20
Waldenstrom macroglobulinemia	D008258		C88.0	4	16	2	—	—	20
Myeloid leukemia acute	D015470		C92.0	11	8	4	—	—	18
Myelodysplastic syndromes	D009190		D46	5	4	2	—	2	11
Philadelphia chromosome	D010677			3	9	2	—	—	11

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			9	1	—	—	3	13
B-cell chronic lymphocytic leukemia	D015451		C91.1	3	11	—	—	—	12
Hematologic neoplasms	D019337			6	4	—	—	—	8
B-cell lymphoma	D016393			6	3	—	—	—	8
Smoldering multiple myeloma	D000075122			—	8	—	—	—	8
Hematologic diseases	D006402	EFO_0005803	D75.9	4	5	—	—	1	7
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218			6	4	—	—	—	6
Neoplasm metastasis	D009362	EFO_0009708		4	4	—	—	—	6
Cholangiocarcinoma	D018281		C22.1	2	4	—	—	—	6
Plasma cell leukemia	D007952		C90.1	2	3	—	—	1	5

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Obesity	D009765	EFO_0001073	E66.9	1	—	—	—	3	4
Polycystic ovary syndrome	D011085	EFO_0000660	E28.2	1	—	—	—	3	4
Central serous chorioretinopathy	D056833		H35.71	1	—	—	—	1	2
Pituitary neoplasms	D010911			1	—	—	—	1	2
Astrocytoma	D001254	EFO_0000271		2	—	—	—	—	2
Oligodendroglioma	D009837	EFO_0000631		2	—	—	—	—	2
Aortic coarctation	D001017	EFO_1001267	Q25.1	1	—	—	—	—	1
Systemic mastocytosis	D034721		C96.21	1	—	—	—	—	1
Hairy cell leukemia	D007943		C91.4	1	—	—	—	—	1
Cluster headache	D003027	HP_0012199	G44.00	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Post-dural puncture headache	D051299			—	—	—	—	3	3
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	—	—	—	3	3
Respiratory sounds	D012135	HP_0010307	R06.1	—	—	—	—	2	2
Myopia	D009216		H52.1	—	—	—	—	2	2
Aortic valve disease	D000082862			—	—	—	—	2	2
Minor planets	D018543			—	—	—	—	2	2
Pituitary acth hypersecretion	D047748	EFO_1001110	E24.0	—	—	—	—	2	2
Cryptorchidism	D003456	EFO_0004562	Q53.1	—	—	—	—	2	2
Glucose intolerance	D018149	HP_0000833	R73.03	—	—	—	—	2	2
Brenner tumor	D001948			—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	DEXAMETHASONE
INN	dexamethasone
Description	Dexamethasone is a fluorinated steroid that is 9-fluoropregna-1,4-diene substituted by hydroxy groups at positions 11, 17 and 21, a methyl group at position 16 and oxo groups at positions 3 and 20. It is a synthetic member of the class of glucocorticoids. It has a role as an adrenergic agent, an antiemetic, an antineoplastic agent, an environmental contaminant, a xenobiotic, an immunosuppressive agent and an anti-inflammatory drug. It is a fluorinated steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a glucocorticoid, a 20-oxo steroid, an 11beta-hydroxy steroid, a 17alpha-hydroxy steroid and a 21-hydroxy steroid. It derives from a hydride of a pregnane.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	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

Identifiers

PDB	4UDA
CAS-ID	50-02-2
RxCUI	3264
ChEMBL ID	CHEMBL384467
ChEBI ID	41879
PubChem CID	5743
DrugBank	DB01234
UNII ID	7S5I7G3JQL (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

NR3C1

NR3C2

Organism

Homo sapiens

Gene name

NR3C1

Gene synonyms

GRL

NCBI Gene ID

2908

Protein name

glucocorticoid receptor

Protein synonyms

Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)

Uniprot ID

Q6N0A4

Mouse ortholog

Nr3c1 (14815)

glucocorticoid receptor (Q61629)

Variants

Clinical Variant

No data

Financial

Ozurdex - Allergan

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Ozurdex - Warner Chilcott

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Ozurdex - AbbVie

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Trends

PubMed Central

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Additional graphs summarizing 175,169 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

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4,050 adverse events reported

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