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Drug ReportsBetamethasone
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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Beta-val, Diprolene, Sernivo (generic drugs available since 1984-10-10, discontinued: Alphatrex, Betaderm, Betatrex, Celestone, Diprosone, Luxiq, 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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Betamethasone
Tradename
Company
Number
Date
Products
CELESTONEMerck & CoN-014215 DISCN1982-01-01
1 products
CELESTONEMerck & CoN-012657 DISCN1982-01-01
1 products
CELESTONEMerck & CoN-014762 DISCN1982-01-01
1 products
Hide discontinued
Betamethasone acetate
+
Betamethasone sodium phosphate
Tradename
Company
Number
Date
Products
CELESTONE SOLUSPANOrganonN-014602 RX1982-01-01
1 products, RLD, RS
Betamethasone benzoate
Tradename
Company
Number
Date
Products
UTICORTPfizerN-016998 DISCN1982-01-01
1 products
UTICORTPfizerN-017244 DISCN1982-01-01
1 products
UTICORTPfizerN-017528 DISCN1982-01-01
1 products
UTICORTPfizerN-018089 DISCN1982-01-01
1 products
Hide discontinued
Betamethasone dipropionate
Tradename
Company
Number
Date
Products
BETAMETHASONE DIPROPIONATEFougera PharmaceuticalsN-019137 RX1984-06-26
1 products, RLD, RS
BETAMETHASONE DIPROPIONATEFougera PharmaceuticalsN-019141 RX1984-09-04
1 products, RLD, RS
DIPROLENEOrganonN-018741 RX1983-07-27
1 products, RLD, RS
SERNIVOPrimus PharmaceuticalsN-208079 RX2016-02-05
1 products, RLD, RS
Show 11 discontinued
Betamethasone dipropionate
+
Calcipotriene
Tradename
Company
Number
Date
Products
TACLONEXLEO PharmaN-021852 RX2006-01-09
1 products, RLD, RS
TACLONEXLEO PharmaN-022185 RX2008-05-09
1 products, RLD, RS
ENSTILARLEO PharmaN-207589 RX2015-10-16
1 products, RLD, RS
WYNZORAMC2 TherapeuticsN-213422 RX2020-07-20
1 products, RLD, RS
Betamethasone dipropionate
+
Clotrimazole
Tradename
Company
Number
Date
Products
LOTRISONEMerck & CoN-020010 DISCN2000-12-08
1 products, RLD
LOTRISONEOrganonN-018827 DISCN1984-07-10
1 products, RLD
Hide discontinued
Betamethasone sodium phosphate
Tradename
Company
Number
Date
Products
CELESTONEMerck & CoN-017561 DISCN1982-01-01
1 products, RLD
Hide discontinued
Betamethasone valerate
Tradename
Company
Number
Date
Products
BETA-VALCosette Pharmaceuticals N-018642 RX1983-03-24
1 products
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018861 RX1983-08-31
1 products, RLD, RS
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018865 RX1983-08-31
1 products, RLD, RS
BETAMETHASONE VALERATEFougera PharmaceuticalsN-018866 RX1983-08-31
1 products, RLD, RS
Show 11 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amolg aunapproved drug other2019-03-15
beta 1 kitANDA2023-12-12
betalido kitunapproved drug other2023-05-10
betaloan suikunapproved drug other2023-07-26
betamethasone dipropionate 0.05% / niacinamide 4%unapproved drug other2019-05-20
betamethasone clotrimazoleANDA2009-10-27
betamethasone dipropionateANDA2024-01-15
betamethasone dipropionate 0.05% / minoxidil 5%unapproved drug other2019-04-24
betamethasone dipropionate 0.05% / minoxidil 5% / niacinamide 2% / pentoxifylline 0.5%unapproved drug other2019-05-08
betamethasone dipropionate betamethasone dipropionate2007-10-09
Show 22 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atopic dermatitisEFO_0000274D003876L20
facial dermatoses—D005148—
foot dermatoses—D005533—
hand dermatoses—D006229—
inflammationMP_0001845D007249—
leg dermatoses—D007868—
pruritus ani—D011538L29.0
psoriasisEFO_0000676D011565L40
scalp dermatoses—D012536—
seborrheic dermatitis—D012628L21
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Betamethasone Dipropionate / Calcipotriene, Wynzora, Mc2
116969192039-03-18DP
102652652027-09-27DP
Betamethasone Dipropionate / Calcipotriene, Enstilar, Leo Pharma As
91197812031-06-10DPU-1761, U-2627
95662862031-06-10DP
101306402031-06-10DP
106176982031-06-10DP
106609082031-06-10DPU-2627
106823642031-06-10DP
106881082031-06-10U-2627
107167992031-06-10DP
Betamethasone Dipropionate, Sernivo, Primus Pharms
93644852030-08-31DPU-1858
94336302030-08-31DPU-1858
94399112030-08-31DPU-1858
96559072030-08-31DPU-1858
97758512030-08-31DPU-1858
98779742030-08-31DPU-1858
101791372030-08-31DPU-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
393 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L402425242312103
Low back painD017116HP_0003419M54.51——2811
Knee osteoarthritisD020370EFO_0004616M17——14611
Atopic dermatitisD003876EFO_0000274L201222411
Premature birthD047928EFO_0003917O60114139
Carpal tunnel syndromeD002349EFO_0004143G56.0——2338
PainD010146EFO_0003843R52———246
Chronic painD059350HP_0012532———1225
Back painD001416HP_0003418M5411—225
Respiratory distress syndromeD012128EFO_1000637J80—13115
Show 44 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Newborn respiratory distress syndromeD012127—P22—21—24
Allergic rhinitisD065631—J30.9——2—13
Covid-19D000086382—U07.1—13——3
PregnancyD011247EFO_0002950Z33.11—1—13
Hip osteoarthritisD015207EFO_1000786M16——1—12
Retinopathy of prematurityD012178EFO_1001158H35.1—21——2
Allergic contact dermatitisD017449—L23—11—12
Hydatidiform moleD006828—O01——1——1
Trophoblastic neoplasmsD014328————1——1
HypoxiaD000860HP_0012418R09.02——1——1
Show 16 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tennis elbowD013716EFO_1001896M77.1—3———3
ArthritisD001168HP_0001369M05-M1422———2
Dry eye syndromesD015352—H04.12—2———2
Rotator cuff injuriesD000070636—M75.1—2———2
ObesityD009765EFO_0001073E66.911———1
Type 2 diabetes mellitusD003924EFO_0001360E1111———1
Ankle injuriesD016512—S93.4—1———1
Colorectal neoplasmsD015179———1———1
Non-small-cell lung carcinomaD002289———1———1
MelanomaD008545———1———1
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plantar fasciitisD036981EFO_1001909M72.21———23
Healthy volunteers/patients———2———13
Post-traumatic headacheD051298—G44.31————1
HypospadiasD007021EFO_0004209Q541————1
VasoconstrictionD014661——1————1
Diabetic retinopathyD003930EFO_0003770—1————1
Penetrating keratoplastyD015948——1————1
ProstatitisD011472EFO_0003830N411————1
Photoallergic dermatitisD017454—L56.21————1
Phototoxic dermatitisD017484——1————1
Show 4 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gestational diabetesD016640HP_0009800O24.4————22
Autoimmune diseasesD001327HP_0002960M30-M36————22
Fetal growth retardationD005317EFO_0000495—————22
Pain measurementD010147——————11
Epidural analgesiaD015360——————11
GoutD006073EFO_0004274M10————11
Hypertrophic cicatrixD017439—L91.0————11
CicatrixD002921HP_0100699L90.5————11
KeloidD007627EFO_0004212L91.0————11
LaparoscopyD010535——————11
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBetamethasone
INNbetamethasone
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)Loading
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-ID378-44-9
RxCUI—
ChEMBL IDCHEMBL632
ChEBI ID3077
PubChem CID9782
DrugBankDB00443
UNII ID9842X06Q6M (ChemIDplus, GSRS)
Target
Agency Approved
NR3C1
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
No data
Financial
Revenue by drug
$
€
£
₣
Wynzora – Novan
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Diprosone – Organon
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Betamethasone – Organon
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Estimated US medical usage
Betamethasone
Total medical expenditures per year (USD, in millions)
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Betamethasone
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Calcipotriene
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Betamethasone
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Clotrimazole
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,511 documents
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Safety
Black-box Warning
Black-box warning for: Marbeta 25 kit, Marbeta l kit
Adverse Events
Top Adverse Reactions
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9,274 adverse events reported
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