Betamethasone

Beta-val, Celestone, Diprolene, Enstilar, Lotrisone, Luxiq, Sernivo, Taclonex, Uticort, Wynzora (betamethasone) is a small molecule pharmaceutical. Betamethasone was first approved as Celestone on 1982-01-01. It is used to treat atopic dermatitis, facial dermatoses, foot dermatoses, hand dermatoses, and inflammation amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor.

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Therapeutic Areas

Therapeutic Area	MeSH
digestive system diseases	D004066
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Beta-val, Diprolene, Luxiq, Sernivo (generic drugs available since 1984-10-10, discontinued: Alphatrex, Betaderm, Betatrex, Celestone, Diprosone, Uticort, Valisone)

Combinations

Celestone soluspan, Enstilar, Taclonex, Wynzora (generic drugs available since 1984-10-10, discontinued: Lotrisone)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Betamethasone

Tradename	Company	Number	Date	Products
CELESTONE	Merck Sharp & Dohme	N-014215 DISCN	1982-01-01	1 products
CELESTONE	Merck Sharp & Dohme	N-012657 DISCN	1982-01-01	1 products
CELESTONE	Merck Sharp & Dohme	N-014762 DISCN	1982-01-01	1 products

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Betamethasone acetate

Betamethasone sodium phosphate

Tradename	Company	Number	Date	Products
CELESTONE SOLUSPAN	Organon	N-014602 RX	1982-01-01	1 products, RLD, RS

Betamethasone benzoate

Tradename	Company	Number	Date	Products
UTICORT	Pfizer	N-016998 DISCN	1982-01-01	1 products
UTICORT	Pfizer	N-017244 DISCN	1982-01-01	1 products
UTICORT	Pfizer	N-017528 DISCN	1982-01-01	1 products
UTICORT	Pfizer	N-018089 DISCN	1982-01-01	1 products

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Betamethasone dipropionate

Tradename	Company	Number	Date	Products
BETAMETHASONE DIPROPIONATE	Fougera Pharmaceuticals	N-019137 RX	1984-06-26	1 products, RLD, RS
BETAMETHASONE DIPROPIONATE	Fougera Pharmaceuticals	N-019141 RX	1984-09-04	1 products, RLD, RS
DIPROLENE	Organon	N-018741 RX	1983-07-27	1 products, RLD, RS
SERNIVO	Primus Pharmaceuticals	N-208079 RX	2016-02-05	1 products, RLD, RS

Show 11 discontinued

Betamethasone dipropionate

Calcipotriene

Tradename	Company	Number	Date	Products
TACLONEX	LEO Pharma	N-021852 RX	2006-01-09	1 products, RLD, RS
TACLONEX	LEO Pharma	N-022185 RX	2008-05-09	1 products, RLD, RS
ENSTILAR	LEO Pharma	N-207589 RX	2015-10-16	1 products, RLD, RS
WYNZORA	MC2 Therapeutics	N-213422 RX	2020-07-20	1 products, RLD, RS

Betamethasone dipropionate

Clotrimazole

Tradename	Company	Number	Date	Products
LOTRISONE	Merck Sharp & Dohme	N-020010 DISCN	2000-12-08	1 products, RLD
LOTRISONE	Organon	N-018827 DISCN	1984-07-10	1 products, RLD

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Betamethasone sodium phosphate

Tradename	Company	Number	Date	Products
CELESTONE	Merck Sharp & Dohme	N-017561 DISCN	1982-01-01	1 products, RLD

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Betamethasone valerate

Tradename	Company	Number	Date	Products
BETA-VAL	Cosette Pharmaceuticals	N-018642 RX	1983-03-24	1 products
BETAMETHASONE VALERATE	Fougera Pharmaceuticals	N-018861 RX	1983-08-31	1 products, RLD, RS
BETAMETHASONE VALERATE	Fougera Pharmaceuticals	N-018865 RX	1983-08-31	1 products, RLD, RS
BETAMETHASONE VALERATE	Fougera Pharmaceuticals	N-018866 RX	1983-08-31	1 products, RLD, RS
LUXIQ	Mylan	N-020934 RX	1999-02-28	1 products, RLD, RS

Show 10 discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
betamethasone dipropionate	ANDA	2023-02-14
celestone soluspan	New Drug Application	2021-06-01
diprolene	New Drug Application	2021-06-01
enstilar	New Drug Application	2021-10-18
luxiq	New Drug Application	2018-04-30
sernivo	New Drug Application	2021-06-23
taclonex	New Drug Application	2022-05-24
wynzora	New Drug Application	2021-12-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
atopic dermatitis	EFO_0000274	D003876	L20
facial dermatoses	—	D005148	—
foot dermatoses	—	D005533	—
hand dermatoses	—	D006229	—
inflammation	MP_0001845	D007249	—
leg dermatoses	—	D007868	—
pruritus ani	—	D011538	L29.0
psoriasis	EFO_0000676	D011565	L40
scalp dermatoses	—	D012536	—
seborrheic dermatitis	—	D012628	L21

Agency Specific

FDA

EMA

Expiration	Code
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, WYNZORA, MC2
2023-07-20	NDF
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, ENSTILAR, LEO PHARMA AS
2023-01-30	PED
BETAMETHASONE DIPROPIONATE / CALCIPOTRIENE, TACLONEX, LEO PHARMA AS
2023-01-25	PED

Patent Expiration

Patent	Expires	Flag	FDA Information
Betamethasone Dipropionate / Calcipotriene, Enstilar, Leo Pharma As
9119781	2031-06-10	DP	U-1761, U-2627
9566286	2031-06-10	DP
10130640	2031-06-10	DP
10617698	2031-06-10	DP
10660908	2031-06-10	DP	U-2627
10682364	2031-06-10	DP
10688108	2031-06-10		U-2627
10716799	2031-06-10	DP
Betamethasone Dipropionate, Sernivo, Primus Pharms
9364485	2030-08-31	DP	U-1858
9433630	2030-08-31	DP	U-1858
9439911	2030-08-31	DP	U-1858
9655907	2030-08-31	DP	U-1858
9775851	2030-08-31	DP	U-1858
9877974	2030-08-31	DP	U-1858
10179137	2030-08-31	DP	U-1858
Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2
10265265	2027-09-27	DP

ATC Codes

A: Alimentary tract and metabolism drugs

— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents

— A07E: Intestinal antiinflammatory agents

— A07EA: Corticosteroids acting locally

— A07EA04: Betamethasone

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

— C05AA05: Betamethasone

D: Dermatologicals

— D07: Corticosteroids, dermatological preparations

— D07A: Corticosteroid dermatological preparations, plain

— D07AC: Corticosteroids, potent (group iii)

— D07AC01: Betamethasone

— D07B: Corticosteroids, combinations with antiseptics

— D07BC: Corticosteroids, potent, combinations with antiseptics

— D07BC01: Betamethasone and antiseptics

— D07C: Corticosteroids, combinations with antibiotics

— D07CC: Corticosteroids, potent, combinations with antibiotics

— D07CC01: Betamethasone and antibiotics

— D07X: Corticosteroids, other combinations

— D07XC: Corticosteroids, potent, other combinations

— D07XC01: Betamethasone

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

— H02: Corticosteroids for systemic use

— H02A: Corticosteroids for systemic use, plain

— H02AB: Glucocorticoids, systemic

— H02AB01: Betamethasone

R: Respiratory system drugs

— R01: Nasal preparations

— R01A: Decongestants and other nasal preparations for topical use

— R01AD: Corticosteroid nasal preparations for topical use

— R01AD06: Betamethasone

— R03: Drugs for obstructive airway diseases

— R03B: Other drugs for obstructive airway diseases, inhalants in atc

— R03BA: Glucocorticoid inhalants for obstructive airway disease

— R03BA04: Betamethasone

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01B: Antiinflammatory agents, ophthalmologic

— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain

— S01BA06: Betamethasone

— S01BB: Corticosteroids and mydriatics in combination

— S01BB04: Betamethasone and mydriatics

— S01C: Antiinflammatory agents and antiinfectives in combination

— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic

— S01CA05: Betamethasone and antiinfectives

— S01CB: Corticosteroids/antiinfectives/mydriatics in combination

— S01CB04: Betamethasone

— S02: Otologicals

— S02B: Corticosteroid otologicals

— S02BA: Corticosteroids

— S02BA07: Betamethasone

— S03: Ophthalmological and otological preparations

— S03B: Corticosteroid ophthalmologic and otologic preparations

— S03BA: Corticosteroids

— S03BA03: Betamethasone

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

— S03CA: Corticosteroids and antiinfectives in combination

— S03CA06: Betamethasone and antiinfectives

HCPCS

Code	Description
J0702	Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg
J7624	Betamethasone, inhalation solution, compounded product, administered through dme, unit dose form, per milligram

Clinical

Clinical Trials

28 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depressive disorder	D003866	EFO_1002014	F32.A	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Xerostomia	D014987		K11.7	—	—	1	—	1	2
Hepatitis c	D006526		B19.2	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	—	1	—	—	1	2
Obesity	D009765	EFO_0001073	E66.9	—	1	—	—	—	1
Hyperoxaluria	D006959		E72.53	—	1	—	—	—	1
Overweight	D050177		E66.3	1	1	—	—	—	1
Homocystinuria	D006712		E72.11	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			2	—	—	—	6	8
Chronic hepatitis c	D019698	EFO_0004220	B18.2	1	—	—	—	1	2
Recurrence	D012008			1	—	—	—	—	1
Male infertility	D007248	EFO_0004248	N46	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	—	2	2
Nervous system diseases	D009422		G00-G99	—	—	—	—	1	1
Angelman syndrome	D017204	Orphanet_72	Q93.51	—	—	—	—	1	1
Insulin resistance	D007333	EFO_0002614		—	—	—	—	1	1
Mucositis	D052016	EFO_1001898		—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	BETAMETHASONE
INN	betamethasone
Description	Betamethasone is a glucocorticoid, a 20-oxo steroid, a 21-hydroxy steroid, a 17alpha-hydroxy steroid, a fluorinated steroid, an 11beta-hydroxy steroid, a 3-oxo-Delta(1),Delta(4)-steroid, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It has a role as an anti-inflammatory drug, an anti-asthmatic agent and an immunosuppressive agent. 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	—
CAS-ID	378-44-9
RxCUI	1514
ChEMBL ID	CHEMBL632
ChEBI ID	3077
PubChem CID	9782
DrugBank	DB00443
UNII ID	9842X06Q6M (ChemIDplus, GSRS)

Target

Agency Approved

NR3C1

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)

Alternate

No data

Variants

Clinical Variant

No data

Financial

Wynzora - Novan

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Diprosone - Organon

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Trends

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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671 adverse events reported

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