> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/hydrocortisone-acetate-6f4eebc7-9cd1-45f5-9f54-435f641fe253
> Record changed: 2026-10-13

# Hydrocortisone acetate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

First approval year

1951

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

## Development status

**First approval year**

1951

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**Drug name**

Hydrocortisone acetate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**Molecular weight**

404.5

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**Structure (SMILES)**

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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

### Brand names (76)

- barquinol hc
- Barquinol hc
- chloromycetin hydrocort
- Chloromycetin hydrocort
- colifoam
- Colifoam
- cortef acetate
- Cortef acetate
- cortifoam
- Cortifoam
- cortril
- Cortril
- cortucid
- Cortucid
- dricort
- Dricort
- epifoam
- Epifoam
- framycort
- Framycort
- fucidin h
- Fucidin h
- genticin hc
- Genticin hc
- gentisone hc

And 51 more, listed on the interactive page.

### Other names (66)

- carmol hc component hydrocortisone acetate
- CARMOL HC COMPONENT HYDROCORTISONE ACETATE
- chloromycetin hydrocortisone component hydrocortisone acetate
- CHLOROMYCETIN HYDROCORTISONE COMPONENT HYDROCORTISONE ACETATE
- coly mycin s component hydrocortisone acetate
- COLY-MYCIN S COMPONENT HYDROCORTISONE ACETATE
- cor oticin component hydrocortisone acetate
- COR-OTICIN COMPONENT HYDROCORTISONE ACETATE
- cortisol 21 acetate
- Cortisol 21-acetate
- epifoam component hydrocortisone acetate
- EPIFOAM COMPONENT HYDROCORTISONE ACETATE
- hydrocortisone 21 acetate
- hydrocortisone 21 acetate mi
- Hydrocortisone 21-acetate
- HYDROCORTISONE 21-ACETATE \[MI\]
- hydrocortisone acetate
- Hydrocortisone acetate
- HYDROCORTISONE ACETATE \[EP IMPURITY\]
- HYDROCORTISONE ACETATE \[EP MONOGRAPH\]
- HYDROCORTISONE ACETATE \[GREEN BOOK\]
- HYDROCORTISONE ACETATE \[JAN\]
- HYDROCORTISONE ACETATE \[MART.\]
- HYDROCORTISONE ACETATE \[ORANGE BOOK\]
- HYDROCORTISONE ACETATE \[USP MONOGRAPH\]

And 41 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 50-03-3

**ChEMBL ID**

CHEMBL1091

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**InChIKey**

ALEXXDVDDISNDU-JZYPGELDSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1091)

**PubChem compound IDs**

- 5744

**FDA ingredient codes (UNII)**

- 3X7931PO74

### RxNorm IDs (RxCUI) (2)

- 27197
- 1007334

## Regulatory information

### United States

**Applicant**

PH HEALTH

**Approval date**

17 May 1962

**Application number**

NDA050356

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Drug name stem**

\-cort-

#### Administration routes

- Parenteral
- topical

### Mechanisms of action

- **Mechanism**  
Glucocorticoid receptor agonist

**Action type**  
Agonist

**Target**  
Glucocorticoid receptor

**Protein identifier**  
P04150

### Open Targets mechanisms

- **Mechanism**  
Glucocorticoid receptor agonist

**Action type**  
Agonist

**Target**  
Glucocorticoid receptor

### DrugCentral mechanisms

- **Action type**  
Agonist

**Gene symbol**  
NR3C1

**Protein identifier**  
P04150

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (7)

- **Condition**  
Dermatitis, Atopic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000274

**Subject identifier**  
D003876
- **Condition**  
Skin Diseases

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000701

**Subject identifier**  
D012871
- **Condition**  
Vitiligo

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0004208

**Subject identifier**  
D014820
- **Condition**  
Hemorrhoids

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0009552

**Subject identifier**  
D006484
- **Condition**  
Pruritus

**Highest recorded phase**  
4

**Condition identifier**  
HP:0000989

**Subject identifier**  
D011537
- **Condition**  
Depressive Disorder

**Highest recorded phase**

0.5

**Condition identifier**  
MONDO:0002050

**Subject identifier**  
D003866
- **Condition**  
Inflammation

**Highest recorded phase**  
4

**Condition identifier**  
MP:0001845

**Subject identifier**  
D007249

### Open Targets indications (13)

- **Condition identifier**  
EFO\_0000701
- **Condition identifier**  
EFO\_0009552

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000989
- **Condition identifier**  
HP\_0000989

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0001072

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002009

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002050
- **Condition identifier**  
MONDO\_0004872

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004980

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005093

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005101

**Highest recorded phase**  
3
- **Condition identifier**  
MP\_0001845
- **Condition identifier**  
MP\_0001845

**Highest recorded phase**  
4

### Reported adverse events (53)

- **Event**  
abdominal discomfort

**Reports**  
577

**Reporting signal score**

753.015
- **Event**  
adrenal insufficiency

**Reports**  
170

**Reporting signal score**

350.215
- **Event**  
adrenocortical insufficiency acute

**Reports**  
78

**Reporting signal score**

249.692
- **Event**  
alopecia

**Reports**  
577

**Reporting signal score**

745.521
- **Event**  
anti-cyclic citrullinated peptide antibody positive

**Reports**  
419

**Reporting signal score**  
1,657.37
- **Event**  
arthralgia

**Reports**  
589

**Reporting signal score**

255.3
- **Event**  
arthropathy

**Reports**  
486

**Reporting signal score**

877.94
- **Event**  
blister

**Reports**  
222

**Reporting signal score**

267.455
- **Event**  
condition aggravated

**Reports**  
564

**Reporting signal score**

312.771
- **Event**  
discomfort

**Reports**  
442

**Reporting signal score**

920.384
- **Event**  
drug hypersensitivity

**Reports**  
1,411

**Reporting signal score**  
1,838.48
- **Event**  
drug intolerance

**Reports**  
550

**Reporting signal score**

667.326
- **Event**  
duodenal ulcer perforation

**Reports**  
219

**Reporting signal score**

766.529
- **Event**  
fatigue

**Reports**  
836

**Reporting signal score**

220.455
- **Event**  
febrile bone marrow aplasia

**Reports**  
282

**Reporting signal score**

910.665
- **Event**  
febrile neutropenia

**Reports**  
311

**Reporting signal score**

302.704
- **Event**  
folliculitis

**Reports**  
120

**Reporting signal score**

274.319
- **Event**  
frequent bowel movements

**Reports**  
114

**Reporting signal score**

178.736
- **Event**  
general physical health deterioration

**Reports**  
210

**Reporting signal score**

140.678
- **Event**  
glossodynia

**Reports**  
484

**Reporting signal score**  
1,432.17
- **Event**  
hand deformity

**Reports**  
469

**Reporting signal score**  
1,563.45
- **Event**  
helicobacter infection

**Reports**  
223

**Reporting signal score**

667.702
- **Event**  
hepatic enzyme increased

**Reports**  
440

**Reporting signal score**

629.532
- **Event**  
hip arthroplasty

**Reports**  
143

**Reporting signal score**

283.355
- **Event**  
hypersensitivity

**Reports**  
574

**Reporting signal score**

550.844

And 28 more, listed on the interactive page.

### Trial references (7)

- NCT00801957  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00801957)
- NCT04615962  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04615962)
- NCT02689856  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02689856)
- NCT03335774  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03335774)
- NCT02837432  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02837432)
- NCT04148261  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04148261)
- NCT03358082  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03358082)

## Dosing

**Route**

Rectal

**How often**

Twice daily

### Conditions of use (2)

- Insert one suppository in the rectum
- Pointed end first

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

2

**Polar surface area**

100.9

**Calculated partition coefficient (ALogP)**

2.35

**Calculated partition coefficient (XLogP)**

2.2

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

29

**Molecular formula**

C23H32O6

**Monoisotopic mass**

404.21988874

**Natural product**

Yes

## National Drug Codes

- 0037-6822
- 0037-6824
- 0037-6830
- 0574-7090
- 0574-7093
- 0713-0493
- 0713-0503
- 0904-7340
- 10135-751
- 13925-160
- 13925-163
- 13925-164
- 13925-165
- 16477-201
- 16477-202
- 16571-164
- 16571-676
- 24470-964
- 24470-965
- 24689-102
- 24689-103
- 28595-050
- 39328-029
- 39328-129
- 44118-704

And 62 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

1,695

**Active assays**

15

### Active assay types (2)

- Confirmatory
- Screening

## Pharmacologic actions

- Anti-Inflammatory Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000893.html)

## Biological measurements

### Observed measurements

#### Distribution coefficient (LogD)

**Median**

2.19

**Mean**

2.175

**Minimum**

2.11

**Maximum**

2.21

**Unit**

unitless

**Assays**

4

**Standard deviation**

0.0443471

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- LogD

## Related records

### Trials (346)

- 05-001: Treatment of Acute Lymphoblastic Leukemia in Children
- 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
- 506U78 in Treating Patients With Refractory Hematologic Cancer
- A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone
- A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
- A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
- A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer
- A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics
- A Pilot Trial of Pediatric Liver Transplantation Without Steroids
- A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
- A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis
- A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas
- A Study in Adults With Untreated Acute Lymphoblastic Leukemia
- A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)
- A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
- [A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)](https://trialight.com/data/trial/a-study-of-opevesostat-mk-5684-versus-alternative-next-40ece519-da89-4905-86a7-0c1a844d57e4.md)
- A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
- A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
- A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
- A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia

### Approved for (1)

- [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md)

### In development for (4)

- [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Phase 2
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Early phase 1
- [Hemorrhoid](https://trialight.com/data/condition/hemorrhoid-bd54316a-50b8-5544-84a5-926f1429bc2a.md) Phase 2
- Vitiligo Phase 1

### Targets (1)

- [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) Glucocorticoid receptor agonist

---

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