dexamethasone

Small moleculeapproved

Approved

Oct 30, 1958

Dexamethasone acetate (NEOFORDEX®) is the acetate salt form of dexamethasone, which is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. At high doses (e.g. 40 mg), it reduces the immune response. Dexamethasone acetate (NEOFORDEX®) is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products. Dexamethasone has been shown to induce multiple myeloma cell death (apoptosis) via a down-regulation of nuclear factor-κB activity and an activation of caspase-9 through second mitochondria-derived activator of caspase (Smac; an apoptosis promoting factor) release. Prolonged exposure was required to achieve maximum levels of apoptotic markers along with increased caspase-3 activation and DNA fragmentation. Dexamethasone also down-regulated anti apoptotic genes and increased IκB-alpha protein levels. Dexamethasone apoptotic activity is enhanced by the combination with thalidomide or its analogues and with proteasome inhibitor (e.g. bortezomib). — NCATS

Clinical trial activity

1,513 trials · 958 clinical orgs · 73 marketing orgs

Phase 1

285

Phase 2

746

Phase 3

293

Phase 4

348

Earliest trial started Jun 1, 2004 (NCT00917241)

Timeline

1950s

Oct 30, 1958
Merck — Earliest FDA Approval
Oct 30, 1958
Merck — NDA Organization
Oct 30, 1958
Merck — NDA Secondary Org

1960s

Dec 21, 1960
Aspen Pharmaceuticals — Marketing Organization
Dec 21, 1960
Aspen Pharmaceuticals — NDA Secondary Org
Jun 20, 1962
Novartis — NDA Secondary Org
Jun 20, 1962
Harrow Health — NDA Secondary Org
Sep 17, 1962
UCB — Marketing Organization
Sep 17, 1962
UCB — NDA Secondary Org

1970s

Oct 20, 1971
Prasco LLC — Marketing Organization
Oct 20, 1971
Ani Pharmaceuticals — Marketing Organization
May 3, 1973
Watson Pharmaceuticals — Marketing Organization
Oct 23, 1973
Alcon — Marketing Organization
Jun 21, 1974
Sun Pharmaceuticals — Marketing Organization
Sep 9, 1974
Phoenix Laboratories — Marketing Organization
Dec 19, 1974
Johnson and Johnson — Marketing Organization
Feb 18, 1975
Whiteworth Towne Paulsen — Marketing Organization
May 19, 1975
Hikma — Marketing Organization
Jul 15, 1975
West-Ward Pharmaceutical — Marketing Organization
Dec 18, 1975
Solvay — Marketing Organization
Jun 29, 1976
Akorn, Inc. — Marketing Organization
Sep 21, 1976
Animas Corporation — Marketing Organization
Feb 8, 1977
Heritage Pharma — Marketing Organization
Sep 6, 1977
Fresenius — Marketing Organization
Jun 6, 1978
Del Laboratories — Marketing Organization
Mar 15, 1979
Belmar Pharmacy — Marketing Organization

1980s

May 29, 1981
Lyphomed, Inc. — Marketing Organization
Jul 21, 1982
Lutipold — Marketing Organization
Apr 28, 1983
Strides Pharma Science — Marketing Organization
Apr 28, 1983
Par Pharmaceuticals — Marketing Organization
Apr 28, 1983
Xspire Pharma — Marketing Organization
Jul 27, 1983
Wockhardt — Marketing Organization
Jul 27, 1983
Xttrium Laboratories — Marketing Organization
Nov 2, 1983
Roxane Laboratories — Marketing Organization
Nov 2, 1983
Boehringer Ingelheim — Marketing Organization
Dec 15, 1983
Fera Development, LLC — Marketing Organization
Dec 15, 1983
Alvogen — Marketing Organization
May 22, 1984
Sandoz — Marketing Organization
Oct 29, 1984
Novartis — Marketing Organization
Apr 9, 1986
Dr. Reddy's Laboratories — Marketing Organization
Jul 21, 1986
Nestle — Marketing Organization
Jul 31, 1989
Perrigo — Marketing Organization
Jul 31, 1989
Padagis Us — Marketing Organization

1990s

Aug 31, 1990
Teva — Marketing Organization
Jul 25, 1994
Bausch & Lomb — Marketing Organization

2000s

Jan 1, 2006
Earliest Phase 2 Sponsor(trial)
Aug 15, 2008
Bausch Health Companies — Marketing Organization
Aug 15, 2008
ECR Pharmaceuticals — Marketing Organization
Aug 29, 2008
Mylan — Marketing Organization
Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
Feb 13, 2009
Eyevance — NDA Secondary Org
Jun 17, 2009
Allergan — Marketing Organization
Jun 17, 2009
AbbVie — Marketing Organization
Jun 17, 2009
AbbVie — NDA Secondary Org

2010s

Jan 1, 2011
Earliest Phase 1 Sponsor(trial)
May 11, 2011
Lannett Company, Inc. — Marketing Organization
May 11, 2011
Chartwell Pharmaceuticals — Marketing Organization
Jul 12, 2011
Lyne Laboratories — Marketing Organization
Dec 1, 2015
Aurobindo Pharma — Marketing Organization
Dec 1, 2015
Eugia Pharma — Marketing Organization
Jul 17, 2017
Larken Labs Inc — Marketing Organization
Feb 9, 2018
Eyepoint Pharmaceuticals — Marketing Organization
Feb 9, 2018
Eyepoint Pharmaceuticals — NDA Secondary Org
Jun 8, 2018
Somerset Pharmaceuticals — Marketing Organization
Aug 22, 2018
Amneal Pharmaceuticals — Marketing Organization
Nov 30, 2018
Ocular Therapeutix, Inc. — Marketing Organization
Nov 30, 2018
Ocular Therapeutix, Inc. — NDA Secondary Org
Oct 3, 2019
Dexcel Pharma Technologies Ltd. — Marketing Organization
Oct 3, 2019
Dexcel Pharma Technologies Ltd. — NDA Secondary Org

2020s

Aug 4, 2021
Gland Pharma Ltd — Marketing Organization
Aug 4, 2021
Fosun — Marketing Organization
Aug 8, 2022
Novitium Pharma — Marketing Organization
Apr 19, 2023
Bionpharma Inc — Marketing Organization
Jun 9, 2023
SENTISS — Marketing Organization
Jul 28, 2023
Geneyork Pharmaceuticals — Marketing Organization
Aug 23, 2023
Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Glucocorticoid receptorAGONIST
NR3C1 agonist
- Glucocorticoid receptor (NR3C1) ↗

Combination products

ciprodex
with ciprofloxacin
decadron w/ xylocaine
with lidocaine
maxitrol
with neomycin, polymyxin b sulfate
Also known as dexacidin, dexasporin, neomycin and polymyxin b sulfates and dexamethasone
neodecadron
with neomycin
tobradex
with tobramycin
Also known as tobradex st

Approval history

approvedPriority reviewOct 30, 1958

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)OCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C

Mol. weight: 434.5 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Discontinued

Oral

Parenteral

Yes

Topical

Sources

Also known as

21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione
aeroseb-dex
aeroseb-dex
al-2512
dalalone
dalalone
decaderm
decaderm
decadron
decadron
decadron
decadron
decadron
decadron-75
decadronal
decadron-la
decadron-la
decadron phosphate
decaspray
decaspray
dexacen-4
dexacen-4
dexacort
dexacort
dexacortisyl
dexafree
dexair
dexair
dexamesathone
dexametasona
dexametasona
dexamethason
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone
dexamethasone 17-valerate
dexamethasone-21-acetate
dexamethasone 21-phosphate
dexamethasone 21-phosphate, (6alpha,11beta,16alpha)-isomer
dexamethasone 21-phosphate, copper (+2) salt (2:3), (11beta,16alpha)-isomer
dexamethasone 21-phosphate, disodium salt, (11beta,16alpha)-isomer
dexamethasone 21-phosphate, disodium salt, (6alpha,11beta,16alpha)-isomer
dexamethasone 21-phosphate, monosodium salt, (11beta,16alpha)-isomer
dexamethasone 21-phosphate, sodium salt, (11beta,16alpha)-isomer
dexamethasone acefurate
dexamethasone acefurate
dexamethasone acefurate
dexamethasone acefurate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate
dexamethasone acetate, (6alpha,11beta)-isomer
dexamethasone cipecilate
dexamethasone dimenhidrinate
dexamethasone dipropionate
dexamethasone dipropionate
dexamethasonedisodium phosphate
dexamethasone intensol
dexamethasone intensol
dexamethasone loaded rbc
dexamethasone metasulfobenzoate sodium
dexamethasone metasulfobenzoate sodium
dexamethasone mixture with tobramycin
dexamethasone palmitate
dexamethasone palmitate
dexamethasone palmitate
dexamethasone palmitate
dexamethasone palmitate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate
dexamethasone phosphate disodium salt
dexamethasone phosphoric acid
dexamethasone phosphoric acid
dexamethasone phosphoric acid
dexamethasone propionate
dexamethasone propionate
dexamethasone propionate
dexamethasone propionate
dexamethasone propionate
dexamethasone sodium hemisulfate
dexamethasone sodium phosphate
dexamethasone sodium phosphate
dexamethasone sodium phosphate
dexamethasone sodium phosphate
dexamethasone sodium phosphate
dexamethasone sodium phosphate
dexamethasone sodium phosphate encapsulated erythrocytes
dexamethasone valerate
dexamethasone valerate
dexamethasone valerate
dexamethasone valerate
dexamethasone valerate
dexamethasone valerate
dexamethasonum
dexamethasonum
dexamethasonum
dexamethazone
dexamethazone
dexamethazone beloxil
dexasone
dexmethsone
dexone
dexone
dexone 0.5
dexone 0.5
dexone 0.75
dexone 0.75
dexone 1.5
dexone 1.5
dexone 4
dexone 4
dexsol
dextralgen
dropodex
egp-437
fluormethylprednisolone
fluormethylprednisolone
gppe ear spy
hexadecadrol
hexadecadrol
hexadrol
hexadrol
ibi-10090
ibi-10090
kortico injection
martapan
maxidex
maxidex
maxitrol
maxitrol
methaderm
mucolox
mymethasone
mymethasone
neodecadron
neodecadron
oradexon
oradexon
otomize
ozurdex
ozurdex
ozurdex
rejuveinix
shp640
sofradex
spersadex
spersadex
spersadex comp
spersadox
tlc599

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07285239	Phase 3	May 31, 2026	GlaxoSmithKline, Mayo Clinic, PrECOG, LLC.
NCT07283705	Phase 2	May 18, 2026	Bristol-Myers Squibb, University of Texas at Houston
NCT07227584	Phase 2	Apr 30, 2026	Harvard University
NCT07247097	Phase 2	Apr 15, 2026	Harvard University, Pfizer
NCT07072585	Phase 2/Phase 3 (Phase 3)	Mar 30, 2026	National Cancer Institute (NCI)
NCT07294677	Phase 1/Phase 2 (Phase 2)	Mar 17, 2026	University of Chicago
NCT07052201	Phase 3	Feb 1, 2026	Chongqing Medical University, Zhejiang University
NCT07082270	Phase 1	Feb 1, 2026	State University of New York, Buffalo
NCT07284758	Phase 2	Jan 31, 2026	C4 Therapeutics, Inc., Medical College of Wisconsin, Royal Marsden Hospital NHS Trust
NCT07287826	Phase 4	Jan 31, 2026	Pennington Biomedical Research Center, Woman's Hospital, Louisiana
NCT07084285	Phase 3	Jan 31, 2026	Assistance Publique - Hôpitaux de Paris
NCT07228052	Phase 4	Jan 30, 2026	Yeshiva University
NCT07222761	Phase 3	Jan 29, 2026	Regeneron
NCT07227311	Phase 2	Jan 14, 2026	GlaxoSmithKline
NCT07289620	N/A	Jan 1, 2026	Poznan University
NCT07294118	Phase 2	Dec 31, 2025	University of Texas, Galveston
NCT07246070	Phase 2	Dec 31, 2025	Chinese Academy of Medical Sciences, Henan Medical University
NCT07297329	Phase 3	Dec 31, 2025	Sinocelltech Ltd.
NCT07255404	Phase 2	Dec 31, 2025	Biontech, Bristol-Myers Squibb
NCT07084441	Phase 4	Dec 31, 2025	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington

Showing 20 of 1,513 trials

Page 1 / 76

Organizations

Research & Development (958)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Cancer Institute (NCI)	Government	68	21	4	2017
Assiut University	Academic/Hospital	41	40	5	2016
Janssen Pharmaceutica NV	For profit	38	4	3	2017
Chinese Academy of Medical Sciences	Academic/Hospital	31	22	5	2010
Bristol-Myers Squibb	For profit	30	4	3	2018
Harvard University	Academic/Hospital	30	23	3	2008
Celgene	For profit	29	10	3	2018
Ocular Therapeutix, Inc.	For profit	29	5	4	2019
Sanofi	For profit	29	13	4	2017
Peking University	Academic/Hospital	28	20	5	2017
Cairo University	Academic/Hospital	27	25	4	2016
Capital Medical University	Academic/Hospital	26	14	5	2018
Ain Shams University	Academic/Hospital	25	25	5	2014
GlaxoSmithKline	For profit	25	14	3	2018
University of Texas at Houston	Academic/Hospital	25	25	4	2017
Poznan University	Academic/Hospital	23	23	2	2023
University of Copenhagen	Academic/Hospital	23	14	4	2017
AbbVie	For profit	22	11	4	2018
Amgen	For profit	22	6	4	2018
Takeda	For profit	20	6	4	2012

958 organizations

Page 1 / 48

Marketing (93)

Organization	Org type	Relationship	Date
AbbVie	For profit	MKTG	Jun 17, 2009
AbbVie	For profit	NDA2	Jun 17, 2009
Abraxis	For profit	MKTG	—
Akorn, Inc.	For profit	MKTG	Jun 29, 1976
Alcon	For profit	MKTG	Oct 23, 1973
Alcon	For profit	SYN	Jul 21, 1986
Allergan	For profit	MKTG	Jun 17, 2009
Alpharma	For profit	MKTG	—
Alvogen	For profit	MKTG	Dec 15, 1983
American Home Products	For profit	MKTG	—
Amneal Pharmaceuticals	For profit	MKTG	Aug 22, 2018
Ani Pharmaceuticals	For profit	MKTG	Oct 20, 1971
Ani Pharmaceuticals	For profit	SYN	Oct 20, 1971
Animas Corporation	For profit	MKTG	Sep 21, 1976
Apotex	For profit	MKTG	Aug 23, 2023
Aspen Pharmaceuticals	For profit	MKTG	Dec 21, 1960
Aspen Pharmaceuticals	For profit	NDA2	Dec 21, 1960
Athenex, Inc.	For profit	MKTG	—
Aurobindo Pharma	For profit	MKTG	Dec 1, 2015
Bausch & Lomb	For profit	MKTG	Jul 25, 1994
Bausch Health Companies	For profit	MKTG	Aug 15, 2008
Belmar Pharmacy	For profit	MKTG	Mar 15, 1979
Bionpharma Inc	For profit	MKTG	Apr 19, 2023
Boehringer Ingelheim	For profit	MKTG	Nov 2, 1983
Century Pharmaceuticals	For profit	MKTG	—
Chartwell Pharmaceuticals	For profit	MKTG	May 11, 2011
Chartwell Pharmaceuticals	For profit	SYN	Feb 8, 1977
Del Laboratories	For profit	MKTG	Jun 6, 1978
Dexcel Pharma Technologies Ltd.	For profit	MKTG	Oct 3, 2019
Dexcel Pharma Technologies Ltd.	For profit	SYN	Oct 3, 2019
Dexcel Pharma Technologies Ltd.	For profit	NDA2	Oct 3, 2019
Dr. Reddy's Laboratories	For profit	MKTG	Apr 9, 1986
Dr. Reddy's Laboratories	For profit	SYN	Aug 10, 2020
ECR Pharmaceuticals	For profit	MKTG	Aug 15, 2008
Eugia Pharma	For profit	MKTG	Dec 1, 2015
Eyepoint Pharmaceuticals	For profit	MKTG	Feb 9, 2018
Eyepoint Pharmaceuticals	For profit	NDA2	Feb 9, 2018
Eyevance	For profit	NDA2	Feb 13, 2009
Fera Development, LLC	For profit	MKTG	Dec 15, 1983
Fosun	For profit	MKTG	Aug 4, 2021
Fresenius	For profit	MKTG	Sep 6, 1977
Geneyork Pharmaceuticals	For profit	MKTG	Jul 28, 2023
Geneyork Pharmaceuticals	For profit	SYN	Jul 7, 2023
Gland Pharma Ltd	For profit	MKTG	Aug 4, 2021
Harrow Health	For profit	NDA2	Jun 20, 1962
Heritage Pharma	For profit	MKTG	Feb 8, 1977
Hikma	For profit	MKTG	May 19, 1975
Hikma	For profit	MKTG	May 19, 1975
Impax Laboratories	For profit	MKTG	—
International Medication	For profit	MKTG	—
Johnson and Johnson	For profit	MKTG	Dec 19, 1974
Lannett Company, Inc.	For profit	MKTG	May 11, 2011
Larken Labs Inc	For profit	MKTG	Jul 17, 2017
Lutipold	For profit	MKTG	Jul 21, 1982
Lyne Laboratories	For profit	MKTG	Jul 12, 2011
Lyphomed, Inc.	For profit	MKTG	May 29, 1981
Merck	For profit	NDA	Oct 30, 1958
Merck	For profit	NDA2	Oct 30, 1958
Mylan	For profit	MKTG	Aug 29, 2008
Mylan	For profit	SYN	Sep 1, 1976
Nestle	For profit	MKTG	Jul 21, 1986
Novartis	For profit	NDA2	Jun 20, 1962
Novartis	For profit	MKTG	Oct 29, 1984
Novitium Pharma	For profit	MKTG	Aug 8, 2022
Ocular Therapeutix, Inc.	For profit	MKTG	Nov 30, 2018
Ocular Therapeutix, Inc.	For profit	NDA2	Nov 30, 2018
Padagis Us	For profit	MKTG	Jul 31, 1989
Par Pharmaceuticals	For profit	MKTG	Apr 28, 1983
Perrigo	For profit	MKTG	Jul 31, 1989
Pharmafair	For profit	MKTG	—
Phoenix Laboratories	For profit	MKTG	Sep 9, 1974
Prasco LLC	For profit	MKTG	Oct 20, 1971
Roxane Laboratories	For profit	MKTG	Nov 2, 1983
SENTISS	For profit	MKTG	Jun 9, 2023
Sandoz	For profit	MKTG	May 22, 1984
Sandoz	For profit	SYN	May 22, 1984
Solvay	For profit	MKTG	Dec 18, 1975
Somerset Pharmaceuticals	For profit	MKTG	Jun 8, 2018
Somerset Pharmaceuticals	For profit	SYN	Apr 19, 2018
Strides Pharma Science	For profit	MKTG	Apr 28, 1983
Sun Pharmaceuticals	For profit	MKTG	Jun 21, 1974
Sun Pharmaceuticals	For profit	SYN	Aug 30, 2022
Teva	For profit	MKTG	Aug 31, 1990
Teva	For profit	SYN	May 24, 1982
UCB	For profit	MKTG	Sep 17, 1962
UCB	For profit	NDA2	Sep 17, 1962
Upsher-Smith Laboratories	For profit	MKTG	—
Watson Pharmaceuticals	For profit	MKTG	May 3, 1973
West-Ward Pharmaceutical	For profit	MKTG	Jul 15, 1975
Whiteworth Towne Paulsen	For profit	MKTG	Feb 18, 1975
Wockhardt	For profit	MKTG	Jul 27, 1983
Xspire Pharma	For profit	MKTG	Apr 28, 1983
Xttrium Laboratories	For profit	MKTG	Jul 27, 1983