Betamethasone - PharmaKB

Betamethasone

Beta-val, Betamethasone, Betamethasone /, Betamethasone / Betamethasone, Celestone, Dermabet, Diprolene, Enstilar, Sernivo, Taclonex, Uticort, Valnac, 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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Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

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, Betamethasone, Dermabet, Diprolene, Sernivo, Valnac (discontinued: Alphatrex, Beta-val, Betaderm, Betamethasone, Betatrex, Celestone, Diprolene, Diprosone, Luxiq, Uticort, Valisone)

Combinations

Betamethasone betamethasone, Calcipotriene betamethasone, Calcipotriene bethamethasone, Celestone soluspan, Clotrimazole betamethasone, Enstilar, Taclonex, Wynzora (discontinued: Calcipotriene betamethasone, Lotrisone)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Betamethasone dipropionate

Calcipotriene

Tradename	Company	Number	Date	Products
ENSTILAR	LEO Pharma	N-207589 RX	2015-10-16	1 products, RLD, RS
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
WYNZORA	MC2 Therapeutics	N-213422 RX	2020-07-20	1 products, RLD, RS

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

Show 11 discontinued

Betamethasone acetate

Betamethasone sodium phosphate

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

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

Clotrimazole

Tradename	Company	Number	Date	Products
LOTRISONE	Merck & Co	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

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

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Betamethasone sodium phosphate

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

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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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Labels

FDA

EMA

Brand Name	Status	Last Update
amolg a	unapproved drug other	2019-03-15
beta 1 kit	ANDA	2024-10-17
betalido kit	unapproved drug other	2024-10-05
betaloan suik	unapproved drug other	2023-07-26
betamethasone dipropionate 0.05% / niacinamide 4%	unapproved drug other	2019-05-20
betamethasone clotrimazole	ANDA	2009-10-27
betamethasone dipropionate	ANDA	2024-10-11
betamethasone dipropionate 0.05% / minoxidil 5%	unapproved drug other	2019-04-24
betamethasone dipropionate 0.05% / minoxidil 5% / niacinamide 2% / pentoxifylline 0.5%	unapproved drug other	2019-05-08
betamethasone dipropionate betamethasone dipropionate		2007-10-09

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
psoriasis	EFO_0000676	D011565	L40
atopic dermatitis	EFO_0000274	D003876	L20
pruritus ani	—	D011538	L29.0
inflammation	MP_0001845	D007249	—
facial dermatoses	—	D005148	—
seborrheic dermatitis	HP_0001051	D012628	L21
foot dermatoses	—	D005533	—
hand dermatoses	—	D006229	—
scalp dermatoses	—	D012536	—
leg dermatoses	—	D007868	—

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Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2
11696919	2039-03-18	DP
10265265	2027-09-27	DP
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

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

401 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Psoriasis	D011565	EFO_0000676	L40	25	29	26	25	15	114
Premature birth	D047928	EFO_0003917	O60	1	5	7	4	10	24
Osteoarthritis	D010003	EFO_0002506	M15-M19	1	—	3	5	10	19
Syndrome	D013577	—	—	—	1	2	3	9	15
Dermatitis	D003872	HP_0011123	L30.9	1	4	4	2	5	15
Knee osteoarthritis	D020370	EFO_0004616	M17	1	—	1	4	7	13
Atopic dermatitis	D003876	EFO_0000274	L20	1	3	3	2	4	13
Back pain	D001416	HP_0003418	M54	1	1	—	3	8	12
Eczema	D004485	HP_0000964	L30.9	1	3	3	2	3	12
Low back pain	D017116	HP_0003419	M54.5	1	—	—	2	8	11

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gout	D006073	EFO_0004274	M10	2	2	1	—	1	4
Hip osteoarthritis	D015207	EFO_1000786	M16	—	—	1	—	2	3
Eye diseases	D005128	EFO_0003966	H44	—	3	1	—	—	3
Covid-19	D000086382	—	—	—	1	3	—	—	3
Inflammation	D007249	MP_0001845	—	—	2	2	—	—	3
Contact dermatitis	D003877	—	L25	—	1	2	—	1	3
Fibrosis	D005355	—	—	2	1	1	—	—	3
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	1	—	1	3
Gouty arthritis	D015210	—	—	2	2	1	—	—	3
Rupture	D012421	—	—	—	2	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rotator cuff injuries	D000070636	—	M75.1	—	2	—	—	4	6
Tennis elbow	D013716	EFO_1001896	M77.1	—	3	—	—	1	4
Diabetes mellitus	D003920	HP_0000819	E08-E13	1	1	—	—	1	2
Wounds and injuries	D014947	—	T14.8	1	1	—	—	—	2
Keratoconjunctivitis sicca	D007638	EFO_1000906	—	—	2	—	—	—	2
Dry eye syndromes	D015352	—	H04.12	—	2	—	—	—	2
Transient tachypnea of the newborn	D059245	—	P22.1	—	1	—	—	1	2
Tachypnea	D059246	HP_0002789	R06.82	—	1	—	—	1	2
Sinusitis	D012852	EFO_0007486	J32	1	2	—	—	—	2
Rhinosinusitis	D000096825	—	—	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
Plantar fasciitis	D036981	EFO_1001909	M72.2	1	—	—	—	2	3
Fasciitis	D005208	HP_0100537	M72.9	1	—	—	—	2	3
Healthy volunteers/patients	—	—	—	2	—	—	—	1	3
Clostridium botulinum type a	D047013	—	—	1	—	—	—	—	1
Headache	D006261	HP_0002315	R51	1	—	—	—	—	1
Neuralgia	D009437	EFO_0009430	—	1	—	—	—	—	1
Post-traumatic headache	D051298	—	G44.3	1	—	—	—	—	1
Hypospadias	D007021	EFO_0004209	Q54	1	—	—	—	—	1
Vasoconstriction	D014661	—	—	1	—	—	—	—	1
Diabetic retinopathy	D003930	EFO_0003770	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyaline membrane disease	D006819	EFO_1000644	P22.0	—	—	—	—	4	4
Gestational diabetes	D016640	HP_0009800	O24.4	—	—	—	—	2	2
Autoimmune diseases	D001327	HP_0002960	M30-M36	—	—	—	—	2	2
Vitiligo	D014820	EFO_0004208	L80	—	—	—	—	2	2
Intervertebral disc displacement	D007405	EFO_1001800	—	—	—	—	—	2	2
Fetal growth retardation	D005317	EFO_0000495	—	—	—	—	—	2	2
Pain measurement	D010147	—	—	—	—	—	—	1	1
Epidural analgesia	D015360	—	—	—	—	—	—	1	1
Somatoform disorders	D013001	—	F45	—	—	—	—	1	1
Hypertrophic cicatrix	D017439	—	L91.0	—	—	—	—	1	1

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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	—
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

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Variants

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Financial

Revenue by drug

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Wynzora – Novan

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Betamethasone – Organon

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Diprosone – Organon

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Estimated US medical usage

Betamethasone

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Betamethasone

Calcipotriene

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Betamethasone

Clotrimazole

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Bl-contrast, Marbeta 25 kit, Marbeta l kit

Adverse Events

Top Adverse Reactions

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13,853 adverse events reported

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