betamethasone

Trade name: celestone

Small moleculeapproved

Approved

Apr 17, 1961

Betamethasone and its derivatives, betamethasone sodium phosphate and betamethasone acetate, are synthetic glucocorticoids. Used for its antiinflammatory or immunosuppressive properties, betamethasone is combined with a mineralocorticoid to manage adrenal insufficiency and is used in the form of betamethasone benzoate, betamethasone dipropionate, or betamethasone valerate for the treatment of inflammation due to corticosteroid-responsive dermatoses. Betamethasone and clotrimazole are used together to treat cutaneous tinea infections. Betamethasone is a glucocorticoid receptor agonist. This leads to changes in genetic expression once this complex binds to the GRE. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Betamethasone binds to plasma transcortin, and it becomes active when it is not bound to transcortin.Betamethasone is used for: treating certain conditions associated with decreased adrenal gland function. It is used to treat severe inflammation caused by certain conditions, including severe asthma, severe allergies, rheumatoid arthritis, ulcerative colitis, certain blood disorders, lupus, multiple sclerosis, and certain eye and skin conditions. — NCATS

Clinical trial activity

294 trials · 315 clinical orgs · 48 marketing orgs

Phase 1

Phase 2

122

Phase 3

Phase 4

Earliest trial started Aug 1, 1993 (NCT00004778)

Timeline

1960s

Apr 17, 1961
Schering-Plough — Earliest FDA Approval
Apr 17, 1961
Schering-Plough — NDA Organization
Apr 17, 1961
Schering — NDA Secondary Org
Apr 13, 1964
Merck — NDA Secondary Org
Mar 3, 1965
Merck — Marketing Organization
Mar 3, 1965
Organon — NDA Secondary Org

1970s

Jun 28, 1974
Parke-Davis — NDA Secondary Org
Jun 28, 1974
Warner Lambert — NDA Secondary Org
Jan 30, 1979
Watson Pharmaceuticals — Marketing Organization

1980s

Mar 24, 1983
ACP Nimble — NDA Secondary Org
Mar 24, 1983
G & W Laboratories Inc. — NDA Secondary Org
Mar 24, 1983
Cosette — Marketing Organization
Mar 24, 1983
Cosette — NDA Secondary Org
Jun 30, 1983
Taro Pharmaceuticals — NDA Secondary Org
Aug 31, 1983
Savage Labs — NDA Secondary Org
Oct 10, 1984
Actavis — Marketing Organization
Oct 26, 1984
Fougera — NDA Secondary Org
May 14, 1985
Taro Pharmaceuticals — Marketing Organization
Jul 31, 1985
STI Pharma, LLC — Marketing Organization
Jul 31, 1985
Animas Corporation — Marketing Organization
Aug 12, 1985
Pharmgen — Marketing Organization
Aug 12, 1985
Fougera — Marketing Organization
Aug 12, 1985
Savage Labs — Marketing Organization
Aug 10, 1987
Teva — Marketing Organization

1990s

Jan 1, 1993
Earliest Phase 3 Sponsor(trial)
Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
Feb 28, 1999
Mylan — NDA Secondary Org
Feb 28, 1999
Mylan — Marketing Organization

2000s

Dec 9, 2003
Padagis Us — Marketing Organization
Jan 23, 2004
ANDA Repository — Marketing Organization
Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
Jan 9, 2006
Leo Pharma — Marketing Organization
Jan 9, 2006
Leo Pharma — NDA Secondary Org
Sep 23, 2008
Glenmark Pharmaceuticals — Marketing Organization
Jul 31, 2009
Sankyo — Marketing Organization
Jul 31, 2009
Lutipold — Marketing Organization
Jul 31, 2009
Daiichi Sankyo — Marketing Organization

2010s

Jan 14, 2013
Tolmar Inc. — Marketing Organization
Dec 12, 2014
Perrigo — Marketing Organization
Feb 5, 2016
Dr. Reddy's Laboratories — NDA Secondary Org
Feb 5, 2016
Encore Dermatology — NDA Secondary Org
Feb 5, 2016
Primus Pharmaceuticals — Marketing Organization
Feb 5, 2016
Primus Pharmaceuticals — NDA Secondary Org
May 24, 2017
Novast Labs — Marketing Organization
May 24, 2017
RiconPharma — Marketing Organization
May 24, 2017
Sun Pharmaceuticals — Marketing Organization
Nov 9, 2017
Pharmaceutical Associates — Marketing Organization
Nov 9, 2017
Teligent Pharmaceuticals — Marketing Organization
Feb 6, 2018
Hi Tech Pharmaceuticals — Marketing Organization
Feb 6, 2018
Akorn, Inc. — Marketing Organization
Jan 11, 2019
Zydus Discovery DMCC — Marketing Organization
Dec 18, 2019
Lupin — Marketing Organization

2020s

Jul 14, 2020
Cadila Healthcare — Marketing Organization
Jul 20, 2020
MC2 Therapeutics — NDA Secondary Org
Feb 18, 2022
Tasman Pharma — Marketing Organization
Jan 17, 2023
Hikma — Marketing Organization
Apr 18, 2023
Exeltis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Glucocorticoid receptorAGONIST
NR3C1 agonist
- Glucocorticoid receptor (NR3C1) ↗

Combination products

lotrisone
with urea
taclonex
with calcipotriene
Also known as enstilar

Approval history

approvedApr 17, 1961

Chemistry & pharmacology

Loading 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)COP(=O)(O)O

Mol. weight: 472.45 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only

Oral

Parenteral

Yes

Topical

Prodrug

Sources

Also known as

16beta-methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione
16beta-methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione
16β-methyl-1,4-pregnadiene-9α-fluoro-11β,17α,21-triol-3,20-dione
16β-methyl-1,4-pregnadiene-9α-fluoro-11β,17α,21-triol-3,20-dione
9alpha-fluoro-16beta-methylprednisolone
9alpha-fluoro-16beta-methylprednisolone
9-fluoro-16beta-methylprednisolone
9-fluoro-16beta-methylprednisolone
9-fluoro-16β-methylprednisolone
9-fluoro-16β-methylprednisolone
9α-fluoro-16β-methylprednisolone
9α-fluoro-16β-methylprednisolone
alphatrex
alphatrex
antebate
antebate
antebate
antebate
audavate
audavate rd
augmented betamethasone dipropionate
bedermin
beloderm
belosalik
bentelan
betacap
betaderm
betaderm
betadexamethasone
betadexamethasone
betadexamethasone
betametasona
betametasona
betametasone
betamethason-17-valerate
betamethason-17-valerate
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone
betamethasone-17,21-dipropionate
betamethasone 17-benzoate
betamethasone 17-benzoate
betamethasone 17 valerate
betamethasone 17 valerate
betamethasone 17-valerate
betamethasone 17-valerate
betamethasone 21-phosphate
betamethasone acetate
betamethasone acetate
betamethasone acetate
betamethasone acetate
betamethasone acetate
betamethasone acetate
betamethasone acetate
betamethasone acibutate
betamethasone acibutate
betamethasone acibutate
betamethasone acibutate
beta-methasone alcohol
beta-methasone alcohol
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone benzoate
betamethasone butyrate propionate
betamethasone butyrate propionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone dipropionate
betamethasone diproprionate
betamethasone disodium phosphate
betamethasone disodium phosphate
betamethasone disodium phosphate, (11beta)-isomer
betamethasone - neomycin
betamethasone, neomycin drug combination
betamethasone phosphate
betamethasone phosphate
betamethasone phosphate
betamethasone phosphate
betamethasone phosphate
betamethasone phosphate
betamethasone phosphoric acid
betamethasone propionate
betamethasone sodium phosphate
betamethasone sodium phosphate
betamethasone sodium phosphate
betamethasone sodium phosphate
betamethasone sodium phosphate
betamethasone sodium phosphate
betamethasone sodium phosphate, (11beta,16beta)-isomer
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethasone valerate
betamethason sodium phosphate
betamethasonum
betamethasonum
betamethasonvalerat mikron
betamethasonvalerat mikron
betamethazone
betameth val 0.1% 50% in emulsif
betameth val in coal tar
betameth val oint0.025% 50%coaltar
betameth val oint 0.1% 25%coal tar
betameth val oint 0.1% 50% coaltar
betam-ophtal
betasolan
betatrex
betatrex
beta-val
beta-val
betesil
bethamethasone
bethamethsaone
betnelan
betnelan
betnesol
betnesol
betnesol
betnesol
betnesol
betnesol-n
betnesol-n
betnovate rd
bettamousse
bettamousse
bextasol
bextasol
bextasol
cd10367
celestone
celestone
celestone
celestone
celestone phosphate
celeston valerate
dermabet
diproderm
diprofos
diprolene
diprolene
diprolene
diprolene af
diprolene af
diprophos
diprophos
diprosis
diprosis
diprosone
diprosone
diprosone
diprosone
diprosone
diprospan
diprospan
diprospan
durabetason
flubenisolone
flubenisolone
fucibet
fucibet
lotrisone
lotrisone
luxiq
luxiq
maxivate
rinderon
rinderon
rinderone
sch-11460
sch-11460
sch-4831
sch-4831
taclonex
taclonex
taclonex
taclonex
uticort
uticort
valisone
valisone
valnac
valnac
vistamethasone
vistamethasone n
w-5975
w-5975
xemacort

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06854380	Early Phase 1 (Phase 1)	Jan 1, 2026	Mansoura University
NCT07256834	Phase 1/Phase 2 (Phase 2)	Nov 22, 2025	Jinnah Postgraduate Medical Centre
NCT07242846	Phase 4	Oct 2, 2025	Nigde Omer Halisdemir University
NCT07131657	Phase 2	Sep 30, 2025	PHARMAFINA
NCT07113756	N/A	Sep 1, 2025	Sohag University
NCT07105540	Phase 4	Aug 5, 2025	Ankara Etlik City Hospital
NCT07078786	Phase 4	Jul 13, 2025	Rawalpindi Medical College, Pakistan
NCT06887322	Phase 1/Phase 2 (Phase 2)	Feb 13, 2025	Padjadjaran University
NCT06863701	Phase 3	Jan 27, 2025	Consultorio Médico "Dr. Rodrigo Suárez Otero", Laboratorios Silanes S.A. de C.V.
NCT06785350	N/A	Jan 25, 2025	Capital Medical University
NCT06715085	Phase 4	Dec 15, 2024	Biotechnology Institute IMASD
NCT06785935	N/A	Nov 11, 2024	—
NCT06916884	Phase 3	Nov 11, 2024	Laboratorios Silanes S.A. de C.V., Unidad de Medicina Especializada SMA
NCT06626568	Phase 2	Oct 15, 2024	Zhejiang University
NCT06643416	Phase 3	Oct 9, 2024	The University of Hong Kong
NCT06527235	Phase 3	Oct 1, 2024	University of Toulouse
NCT06577077	Phase 3	Sep 30, 2024	Ache Laboratorios Farmaceuticos S.A.
NCT05981118	Phase 2/Phase 3 (Phase 3)	Jul 15, 2024	Roivant Sciences, Inc., Wake Forest University
NCT06321354	N/A	Mar 20, 2024	Capital Medical University
NCT06299813	Phase 3	Mar 20, 2024	Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

Showing 20 of 294 trials

Page 1 / 15

Organizations

Research & Development (315)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Leo Pharma	For profit	37	31	5	2004
Cairo University	Academic/Hospital	8	8	4	2016
MC2 Therapeutics	For profit	7	7	3	2017
Windsor Dermatology	Academic/Hospital	6	4	3	2008
Dr. Reddy's Laboratories	For profit	5	5	2	2013
Novartis	For profit	5	5	3	2003
Zhejiang University	Academic/Hospital	5	4	2	2015
Capital Medical University	Academic/Hospital	4	4	2	2011
Derm Research, PLLC	For profit	4	4	1	2008
EMS S/A	For profit	4	4	1	2012
Icahn School of Medicine at Mount Sinai	Academic/Hospital	4	1	4	2010
Tel Aviv University	Academic/Hospital	4	4	3	2012
University of California, San Francisco	Academic/Hospital	4	2	2	2008
University of Copenhagen	Academic/Hospital	4	3	2	1998
Ain Shams University	Academic/Hospital	3	3	3	2010
Assiut University	Academic/Hospital	3	3	3	2022
Astellas	For profit	3	3	1	2004
Fudan University	Academic/Hospital	3	0	3	2005
Henry Ford Health System	Academic/Hospital	3	0	2	2010
National Institutes of Health (NIH)	Government	3	0	1	1993

315 organizations

Page 1 / 16

Marketing (67)

Organization	Org type	Relationship	Date
ACP Nimble	For profit	NDA2	Mar 24, 1983
ANDA Repository	For profit	MKTG	Jan 23, 2004
Actavis	For profit	MKTG	Oct 10, 1984
Akorn, Inc.	For profit	MKTG	Feb 6, 2018
Alpharma	For profit	MKTG	—
Animas Corporation	For profit	MKTG	Jul 31, 1985
Cadila Healthcare	For profit	MKTG	Jul 14, 2020
Cosette	For profit	MKTG	Mar 24, 1983
Cosette	For profit	NDA2	Mar 24, 1983
Daiichi Sankyo	For profit	MKTG	Jul 31, 2009
Dr. Reddy's Laboratories	For profit	NDA2	Feb 5, 2016
Encore Dermatology	For profit	NDA2	Feb 5, 2016
Exeltis	For profit	MKTG	Apr 18, 2023
Fougera	For profit	NDA2	Oct 26, 1984
Fougera	For profit	SYN	Aug 31, 1983
Fougera	For profit	MKTG	Aug 12, 1985
G & W Laboratories Inc.	For profit	NDA2	Mar 24, 1983
Glenmark Pharmaceuticals	For profit	MKTG	Sep 23, 2008
Glenmark Pharmaceuticals	For profit	SYN	Oct 30, 2015
Glenmark Pharmaceuticals	For profit	SYN	Mar 21, 2023
Hi Tech Pharmaceuticals	For profit	MKTG	Feb 6, 2018
Hikma	For profit	MKTG	Jan 17, 2023
Leo Pharma	For profit	MKTG	Jan 9, 2006
Leo Pharma	For profit	NDA2	Jan 9, 2006
Lupin	For profit	MKTG	Dec 18, 2019
Lutipold	For profit	MKTG	Jul 31, 2009
MC2 Therapeutics	For profit	NDA2	Jul 20, 2020
Merck	For profit	NDA2	Apr 13, 1964
Merck	For profit	MKTG	Mar 3, 1965
Mylan	For profit	NDA2	Feb 28, 1999
Mylan	For profit	MKTG	Feb 28, 1999
Novast Labs	For profit	MKTG	May 24, 2017
Organon	For profit	NDA2	Mar 3, 1965
Padagis Us	For profit	MKTG	Dec 9, 2003
Padagis Us	For profit	MKTG	Jan 31, 1990
Parke-Davis	For profit	NDA2	Jun 28, 1974
Perrigo	For profit	MKTG	Dec 12, 2014
Perrigo	For profit	SYN	Jan 31, 1990
Perrigo	For profit	SYN	Nov 26, 2012
Pharmaceutical Associates	For profit	MKTG	Nov 9, 2017
Pharmaderm	For profit	NDA2	—
Pharmafair	For profit	MKTG	—
Pharmgen	For profit	MKTG	Aug 12, 1985
Primus Pharmaceuticals	For profit	MKTG	Feb 5, 2016
Primus Pharmaceuticals	For profit	NDA2	Feb 5, 2016
RiconPharma	For profit	MKTG	May 24, 2017
STI Pharma, LLC	For profit	MKTG	Jul 31, 1985
Sankyo	For profit	MKTG	Jul 31, 2009
Savage Labs	For profit	NDA2	Aug 31, 1983
Savage Labs	For profit	MKTG	Aug 12, 1985
Schering	For profit	NDA2	Apr 17, 1961
Schering-Plough	For profit	NDA	Apr 17, 1961
Sun Pharmaceuticals	For profit	MKTG	May 24, 2017
Taro Pharmaceuticals	For profit	MKTG	May 14, 1985
Taro Pharmaceuticals	For profit	SYN	May 24, 2017
Taro Pharmaceuticals	For profit	SYN	Jun 30, 1983
Taro Pharmaceuticals	For profit	SYN	Jun 17, 2020
Taro Pharmaceuticals	For profit	NDA2	Jun 30, 1983
Tasman Pharma	For profit	MKTG	Feb 18, 2022
Teligent Pharmaceuticals	For profit	MKTG	Nov 9, 2017
Teligent Pharmaceuticals	For profit	SYN	Nov 9, 2017
Teva	For profit	MKTG	Aug 10, 1987
Teva	For profit	SYN	Apr 22, 1988
Tolmar Inc.	For profit	MKTG	Jan 14, 2013
Warner Lambert	For profit	NDA2	Jun 28, 1974
Watson Pharmaceuticals	For profit	MKTG	Jan 30, 1979
Zydus Discovery DMCC	For profit	MKTG	Jan 11, 2019