hydrocortisone

Trade name: solu-cortef

Small moleculeapproved

Approved

Apr 27, 1955

Hydrocortisone valerate is a synthetic glucocorticoid corticosteroid and a corticosteroid ester. It can be used as a medicine to treat itching, swelling, and other skin conditions. — Wikipedia

Clinical trial activity

193 trials · 229 clinical orgs · 30 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Mar 1, 2003 (NCT00801957)

Timeline

1950s

Apr 27, 1955
Earliest FDA Approval
Apr 27, 1955
Pharmacia & Upjohn — NDA Secondary Org

1970s

Mar 17, 1978
Sun Pharmaceuticals — NDA Secondary Org
Mar 28, 1978
Abbott — Marketing Organization
Mar 28, 1978
Hospira — Marketing Organization

1980s

May 28, 1981
Baxalta — Marketing Organization
May 28, 1981
Baxter — Marketing Organization
Mar 31, 1982
PreCision Dermatology — NDA Secondary Org
Mar 31, 1982
Bausch Health Companies — NDA Secondary Org

1990s

Feb 28, 1997
Fougera — NDA Secondary Org
Feb 28, 1997
Ani Pharmaceuticals — Marketing Organization
Feb 28, 1997
Ani Pharmaceuticals — NDA Secondary Org
Aug 12, 1998
ACP Nimble — Marketing Organization
Aug 12, 1998
G & W Laboratories Inc. — Marketing Organization
Aug 25, 1998
Taro Pharmaceuticals — Marketing Organization

2000s

May 24, 2000
Padagis Us — Marketing Organization
May 24, 2000
Perrigo — Marketing Organization
Jul 31, 2001
Fougera — Marketing Organization
Jan 1, 2003
Earliest Phase 2 Sponsor(trial)

2010s

Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
Nov 21, 2017
Pharmaceutical Associates — Marketing Organization
Nov 21, 2017
Teligent Pharmaceuticals — Marketing Organization
Nov 21, 2017
THE J MOLNER — Marketing Organization
Dec 8, 2017
Actavis — Marketing Organization
Dec 8, 2017
Allergan PLC (2015) — Marketing Organization
Oct 12, 2018
Glenmark Pharmaceuticals — Marketing Organization
Aug 15, 2019
Lupin — Marketing Organization

2020s

Mar 4, 2020
Cosette — Marketing Organization
Nov 4, 2021
Encube Ethicals Pvt. Ltd. — Marketing Organization
Sep 5, 2024
Cipla — Marketing Organization

Indications

Studied for

Mechanism of action

Glucocorticoid receptorAGONIST
NR3C1 agonist
- Glucocorticoid receptor (NR3C1) ↗
Glucocorticoid receptorAGONIST
Glucocorticoid receptor agonist
Approved veterinary
- Glucocorticoid receptor (NR3C1) ↗
- Glucocorticoid receptor (A0A8C0QLS2) ↗

Approval history

approvedApr 27, 1955

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CCC(=O)C=C1CC[C@@H]1[C@@H]2[C@@H](O)C[C@@]2(C)[C@H]1CC[C@]2(O)C(=O)COC(=O)CCC(=O)O.O

Mol. weight: 480.55 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Prescription Only

Oral

Parenteral

Topical

Prodrug

Sources

Also known as

acetasol hc
acetasol hc
acticort
acticort
acticort
acyclovir mixture with hydrocortisone
aeroseb-hc
aeroseb-hc
a-hydrocort
a-hydrocort
a-hyrocort
ala-cort
ala-cort
ala-scalp
ala-scalp
alphaderm
alphaderm
alphaderm
anflam
anflam
anucort-hc
anucort-hc
anugesic hc
anusol hc
anusol hc
anusol-hc
anusol-hc
anusol plus hc
anusol soothing relief
balneol-hc
balneol-hc
barquinol hc
beta-hc
beta-hc
calmurid hc
calmurid hc
canesten hc
canesten hc
canesten hc
cetacort
cetacort
cetacort
cipro hc
cipro hc
cobadex
cobadex
colifoam
colifoam
colifoam
colocort
colocort
corlan
corlan
cor-oticin
cor-oticin
cort-dome
cort-dome
cortef
cortef
cortef acetate
cortef acetate
cortenem
cortenema
cortenema
cortifoam
cortifoam
cortifoam
cortisol
cortisol
cortisol
cortisol
cortisol
cortisol 17-butyrate
cortisol 21-acetate
cortisol-21-(hydrogen succinate)
cortisol 21-phosphate
cortisol acetate
cortisol cypionate
cortisol hemisuccinate
cortisol succinate
cortisol succinate, sodium salt
cortisporin
cortril
cortril
cortucid
daktacort
daktacort
daktacort hydrocort
derma care hydrocort
dermacort
dermacort
dermaspray demang
dioderm
dioderm
dome-cort
dome-cort
econacort
efcortelan p
eldecort
eldecort
epicort
epicort
epifoam
epifoam
epifoam
eurax-hc
eurax-hydrocort
evacort
evacort
exe-cort
flexicort
flexicort
framycort
framycort
fucidin h
genticin hc
gentisone hc
germoloids hc
glycort
glycort
gppe ear susp
gppe eye crm
gppe foam aero
gregoderm
hc #1
hc #1
hc #4
hc #4
hc45
hc45
hc45 hydrocort
h-cort
h-cort
hcss
hemsol-hc
hepacort plus
hi-cor
hi-cor
hidrocortisona
hidrocortisona
hydracort
hydrasson
hydrocal
hydrocortancyl
hydrocort in calamine oily
hydrocort in cetomacrogol for a
hydrocort in wte soft paraf
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone
hydrocortisone 17alpha-butyrate
hydrocortisone 17-butyrate
hydrocortisone 17-butyrate
hydrocortisone 17-butyrate
hydrocortisone 17-butyrate
hydrocortisone-17-butyrate
hydrocortisone 17-butyrate 21-propionate
hydrocortisone 21-acetate
hydrocortisone 21-cyclopentylpropionate
hydrocortisone 21-hemisuccinate sodium salt
hydrocortisone 21-phosphate
hydrocortisone 21-sodium succinate
hydrocortisone aceponate
hydrocortisone aceponate
hydrocortisone aceponate
hydrocortisone aceponate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate
hydrocortisone acetate, (11alpha)-isomer
hydrocortisone acetate, (11beta,17alpha)-isomer
hydrocortisone acetate, (11beta)-isomer
hydrocortisone acetate, monoammonium salt, (11beta)-isomer
hydrocortisone acetate, sodium salt
hydrocortisone buteprate
hydrocortisone buteprate
hydrocortisone buteprate
hydrocortisone buteprate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate
hydrocortisone butyrate propionate
hydrocortisone butyrate propionate
hydrocortisone cipionate
hydrocortisone cipionate
hydrocortisone cyclopentylpropionate
hydrocortisone cyclopentylpropionate
hydrocortisone cyclopentylpropionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone cypionate
hydrocortisone hemisuccinate
hydrocortisone hemisuccinate
hydrocortisone hemisuccinate
hydrocortisone hemisuccinate
hydrocortisone hemisuccinate
hydrocortisone in absorbase
hydrocortisone in absorbase
hydrocortisone - neomycin - polymyxin b
hydrocortisone, neomycin, polymyxin b drug combination
hydrocortisone - oxytetracycline
hydrocortisone, oxytetracycline drug combination
hydrocortisone pentanoate
hydrocortisone phosphate
hydrocortisone phosphate
hydrocortisone phosphate
hydrocortisone phosphoric acid
hydrocortisone probutate
hydrocortisone probutate
hydrocortisone probutate
hydrocortisone probutate
hydrocortisone probutate
hydrocortisone sodium phosphate
hydrocortisone sodium phosphate
hydrocortisone sodium phosphate
hydrocortisone sodium phosphate
hydrocortisone sodium succinate
hydrocortisone sodium succinate
hydrocortisone sodium succinate
hydrocortisone sodium succinate
hydrocortisone sodium succinate
hydrocortisone sodium succinate
hydrocortisone succinate
hydrocortisone succinate
hydrocortisone succinate
hydrocortisone succinate
hydrocortisone succinate
hydrocortisone - urea
hydrocortisone, urea drug combination
hydrocortisone valerate
hydrocortisone valerate
hydrocortisone valerate
hydrocortisone valerate
hydrocortisone valerate
hydrocortisone valerate
hydrocortisone valerate
hydrocortisonum
hydrocortisonum
hydrocortisyl
hydrocortone
hydrocortone
hydrocortone
hydroderm
hydroderm hc
hydrodexan
hydromol intensive
hydro-rx
hydro-rx
hydroxycorticosterone acetate
hytone
hytone
jungle for
laticort
locoid
locoid
locoid
locoid
locoid c
locoid c
locoid crelo
locoid lipocream
medicort
medicort
micort-hc
mildison lipocream
neo-cortef
neo-cortef
nogenic hc
nogenic hc
nsc-7576
nsc-7576
nutracort
nutracort
nybadex
nystaform-hc
nystaform-hc
ophthocort
ophthocort
otoseptil
otosporin
otosporin
otosporin
pandel
pandel
pandel
pandel
penecort
penecort
perinal
plenadren
plenadren
plenadren
pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, (11beta)-
proctocort
proctocort
proctocream hc
proctofoam hc
proctofoam hc
proctosedyl
proctosedyl
quinocort
sential hc
solu-cortef
solu-cortef
solu-cortef
solu-cortef
sopolcort h
sopolkort
stie-cort
stie-cort
synacort
synacort
terracortril
terra-cortril
terra-cortril
terra-cortril
terra-cortril nystatin
tesi
texacort
texacort
timocort
timocort
timodine
timodine
topisone
tri-cicatrin
u-cort
uniroid
uniroid hc
westcort
westcort
westcort
xyloproct
zenoxone
zenoxone

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07175415	Phase 1/Phase 2 (Phase 2)	Oct 1, 2026	AbbVie, AstraZeneca, Humboldt University, Princess Maxima Center for Pediatric Oncology
NCT07072585	Phase 2/Phase 3 (Phase 3)	Mar 30, 2026	National Cancer Institute (NCI)
NCT06881927	Phase 4	Feb 1, 2026	University of Strasbourg
NCT07304739	Phase 2	Dec 22, 2025	Tianjin Medical University
NCT06942039	Early Phase 1 (Phase 1)	Sep 30, 2025	C17 Council
NCT07190196	Phase 3	Sep 26, 2025	Sanofi
NCT07124650	Phase 4	Sep 15, 2025	Saint-Petersburg State Medical University
NCT07037043	Phase 3	Aug 31, 2025	Rouen Normandy University, University of Lille, University of Picardie Jules Verne
NCT06892197	Phase 4	Aug 1, 2025	University of Copenhagen
NCT06892210	Phase 4	Aug 1, 2025	University of Copenhagen
NCT06982183	Phase 4	May 27, 2025	United States Army
NCT06895473	Phase 2	Apr 1, 2025	American Society of Clinical Oncology, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06247787	Phase 1	Mar 28, 2025	Geron Corporation, National Cancer Institute (NCI)
NCT07248761	Phase 4	Feb 1, 2025	Government of Mexico, Instituto Mexicano del Seguro Social
NCT06317662	Phase 2	Jan 26, 2025	National Cancer Institute (NCI)
NCT06390319	Phase 2	Dec 31, 2024	AbbVie, St. Jude Children's Hospital
NCT06289673	Phase 4	Dec 31, 2024	St. Jude Children's Hospital
NCT06504160	Phase 2	Dec 15, 2024	National Institute of Allergy and Infectious Diseases (NIAID), National Jewish Health, Rho, Inc., University of California, San Diego
NCT06654596	N/A	Nov 30, 2024	Fudan University, Jiao Tong University, Second Military Medical University, Shanghai Longhua Hospital, Sichuan University, Wannan Medical College, Wuhan University, Yijishan Hospital of Wannan Medical College
NCT07154849	Phase 4	Nov 11, 2024	Ain Shams University

Showing 20 of 193 trials

Page 1 / 10

Organizations

Research & Development (229)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Cancer Institute (NCI)	Government	10	8	3	2018
Diurnal Limited	For profit	7	7	3	2017
St. Jude Children's Hospital	Academic/Hospital	7	7	3	2019
AbbVie	For profit	6	1	2	2021
Humboldt University	Academic/Hospital	5	2	2	2014
Innovative Therapies For Children with Cancer Consortium	Academic/Hospital	5	0	1	2018
National Institutes of Health (NIH)	Government	5	0	2	2018
Princess Maxima Center for Pediatric Oncology	Academic/Hospital	5	5	1	2023
University of Copenhagen	Academic/Hospital	5	4	2	2016
Wayne State University	Academic/Hospital	5	4	2	2016
Ain Shams University	Academic/Hospital	4	4	2	2018
Fight Kids Cancer	Academic/Hospital	4	0	1	2023
Harvard University	Academic/Hospital	4	3	3	2018
Merck	For profit	4	4	2	2023
National Institute on Drug Abuse (NIDA)	Government	4	0	1	2016
AVM Biotechnology LLC	For profit	3	3	2	2020
Brush Clinical Research Ltd.	For profit	3	0	1	2017
Chinese Academy of Medical Sciences	Academic/Hospital	3	2	2	2019
Emas Pharma Ltd.	For profit	3	0	1	2017
Fudan University	Academic/Hospital	3	2	2	2023

229 organizations

Page 1 / 12

Marketing (39)

Organization	Org type	Relationship	Date
ACP Nimble	For profit	MKTG	Aug 12, 1998
Abbott	For profit	MKTG	Mar 28, 1978
Abraxis	For profit	MKTG	—
Actavis	For profit	MKTG	Dec 8, 2017
Allergan PLC (2015)	For profit	MKTG	Dec 8, 2017
Ani Pharmaceuticals	For profit	MKTG	Feb 28, 1997
Ani Pharmaceuticals	For profit	NDA2	Feb 28, 1997
Bausch Health Companies	For profit	NDA2	Mar 31, 1982
Baxalta	For profit	MKTG	May 28, 1981
Baxter	For profit	MKTG	May 28, 1981
Cipla	For profit	MKTG	Sep 5, 2024
Cosette	For profit	SYN	Mar 4, 2020
Cosette	For profit	MKTG	Mar 4, 2020
Encube Ethicals Pvt. Ltd.	For profit	MKTG	Nov 4, 2021
Fougera	For profit	NDA2	Feb 28, 1997
Fougera	For profit	MKTG	Jul 31, 2001
G & W Laboratories Inc.	For profit	MKTG	Aug 12, 1998
Glenmark Pharmaceuticals	For profit	MKTG	Oct 12, 2018
Glenmark Pharmaceuticals	For profit	SYN	Sep 27, 2013
Hospira	For profit	MKTG	Mar 28, 1978
International Medication	For profit	MKTG	—
Lupin	For profit	MKTG	Aug 15, 2019
Padagis Us	For profit	MKTG	May 24, 2000
Perrigo	For profit	SYN	May 24, 2000
Perrigo	For profit	MKTG	May 24, 2000
Pharmaceutical Associates	For profit	MKTG	Nov 21, 2017
Pharmacia & Upjohn	For profit	NDA2	Apr 27, 1955
PreCision Dermatology	For profit	NDA2	Mar 31, 1982
Sun Pharmaceuticals	For profit	NDA2	Mar 17, 1978
Sun Pharmaceuticals	For profit	SYN	Mar 17, 1978
THE J MOLNER	For profit	MKTG	Nov 21, 2017
Taro Pharmaceuticals	For profit	SYN	Jan 14, 2004
Taro Pharmaceuticals	For profit	SYN	Dec 27, 2004
Taro Pharmaceuticals	For profit	MKTG	Aug 25, 1998
Teligent Pharmaceuticals	For profit	MKTG	Nov 21, 2017
Teligent Pharmaceuticals	For profit	SYN	Nov 21, 2017
Upjohn	For profit	NDA	—
Watson Pharmaceuticals	For profit	MKTG	—
Yamanouchi Pharmaceuticals	For profit	NDA2	—