Clascoterone 10mg/g cream

50%

Azelaic acid 15% gel

Gel

15%

Generic Actinac lotion

Aluminium oxide 52% paste

52%

Aluminium oxide 38% paste

38%

Drug monograph — bnf.nice.org.uk

Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.

NHS prescribing volume and spending trends

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Clinical guidelines and formulary information

British National Formulary

Clascoterone

BNF

Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.

NICE clinical guidance(1)

Clascoterone for treating acne vulgaris in people 12 years and over (terminated appraisal) (TA1105)

TA1105

Technology appraisal

Updated Oct 2025

Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.

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PMID: 32320027 DOI: 10.1001/jamadermatol.2020.0465

Supply & product information

Official product databases and supply status monitoring

Shortages info

NHS Specialist Pharmacy Service (SPS)

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Codes for healthcare professionals and prescribing systems

Show details

These codes are used by healthcare IT systems and prescribers to identify this medicine.

NHS UK identifiers

SNOMED CT

44882611000001100

dm+d ID

44882611000001100

VTM (Virtual Therapeutic Moiety)

898165001

VMP (Virtual Medicinal Product)

44882611000001100

BNF code

13060100

International identifiers

ATC code — Anatomical Therapeutic Chemical (WHO)

D10AX06

Browse tools

dm+d Browser

NHSBSA medicines dictionary lookup

SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).

Active and completed clinical studies from ClinicalTrials.gov

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Searching UK clinical trials...

Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.

Pharmacology and chemical data from DrugBank

go.drugbank.com

Key facts

Drug status

Approved

Major interactions

None known

Half-life

Not available

Mechanism

Acne is a multifactorial skin condition characterized by excess sebum production…

Food interactions

None known

Human targets

1 target

Data: DrugBank · CC BY-NC 4.0

Pharmacokinetics at a glance

Absorption

2.9 ng/mL

Upon topical application, clascoteronet permeates the skin to the dermal levels with minimal systemic absorption.
[A218776]…

Half-life

There is limited information on the half life of clascoterone.
[L15626]

Protein binding

84%

Clascoterone is 84% to 89% bound to plasma proteins in vitro, regardless of drug concentrations.
[L15626]

Volume of distribution

There is no information available on the volume of distribution.

Metabolism

0.5 ng/mL

According to in vitro and clinical studies, the main possible primary metabolite of clascoterone is cortexolone, which is an inactive metabolite.…

Elimination

Excretion of clascoterone has not been fully characterized in humans.
[L15626]…

Clearance

There is limited information on clearance of clascoterone.
[L15626]

Pharmacokinetic data: DrugBank · CC BY-NC 4.0

Status:

Approved

Investigational

Small molecule

About this compound

Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity.[A218771] By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways.[A218846] In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older.[L15621] Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.[A218766]

Properties:

solid

Avg. mass: 402.53 Da

DrugBank indication

Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
[L15626][L47011]

Also known as(74)

11-deoxycortisol 17α-propionate

Clascoterone

Cortexolone 17alpha-propionate

Cortexolone 17α-propionate

DHTR

Dihydrotestosterone receptor

NR3C4

Nuclear receptor subfamily 3 group C member 4

Dosage forms(2)

Cream (Topical) — 1 % w/w

Cream (Topical) — 1 g/100g

Molecular properties(19)

Drug interactions(1)

Known interactions with other medications. Always consult a healthcare professional.

Flotufolastat F-18

Moderate

DB17851

Clascoterone may decrease effectiveness of Flotufolastat F-18 as a diagnostic agent.

Check this interaction

Showing 1 of 1 interactions

Toxicity & overdose

There is no information available on the toxicity profile of clascoterone, such as LD₅₀ and overdose in humans.

How it works

Mechanism of action

Acne is a multifactorial skin condition characterized by excess sebum production, epithelial hyperkeratinization, proliferation of the skin commensal bacteria, and inflammation.[A218761][A218771] Circulating and locally synthesized natural ligands, testosterone and dihydrotestosterone (DHT), serve as causative factors in both males and females. Upon binding of DHT, the DHT-androgen receptor complex dimerizes and translocates to the nucleus where it promotes the transcription of genes involved in acne pathogenesis, including proliferation and differentiation of sebocytes, excess sebum production, and inflammatory cytokine production.[A218771] Clascoterone is a potent antagonist at ARs and competes for androgens in binding to the receptor, thereby inhibiting downstream signalling of ARs that promote acne.[A218761]

Androgenetic alopecia is also an androgen-dependent and highly genetic condition. Dihydrotestosterone (DHT) binds to ARs expressed on dermal papilla cells (DPC) in the scalp to induce AR-mediated transcription of genes that contribute to androgenic alopecia. By blocking the interaction between DHT and aARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.[A218766]

Pharmacodynamics

Clascoterone exerts anti-androgenic effects by working as an antagonist at androgen receptors (ARs) expressed throughout the skin, including sebaceous glands, sebocytes, and dermal papilla cells.[A218761] Clascoterone blocks the effects of testosterone and dihydrotestosterone (DHT), which are androgens that bind to the ARs and contribute to the development of androgen-dependent conditions such as acne and alopecia.[A218761] In vitro, the antiandrogenic effects of clascoterone in human primary sebocytes occurred in a dose-dependent manner.[A218771] Clascoterone mediates selective topical activity by mainly targeting androgen receptors at the site of application. It has limited systemic effects.[A218761]

In clinical trials, HPA axis suppression was observed as a 30-minute post-stimulation serum cortisol level of ≤18 mcg/dL in 5% of adult subjects and 9% of adolescent subjects with acne vulgaris following two weeks of topical treatment of clascoterone. HPA axis function returned to normal following the discontinuation of drug treatment.[L15626]

Pharmacokinetics

How the body processes this drug — absorption, distribution, metabolism, and elimination

Absorption

Upon topical application, clascoteronet permeates the skin to the dermal levels with minimal systemic absorption.
[A218776]
In clinical trials, adult subjects with moderate to severe facial acne vulgaris received twice-daily topical application of six grams of clascoterone. The steady-state concentrations of the drug were reached within five days. Following two weeks, the mean ± SD Cmax was 4.5 ± 2.9 ng/mL and the mean ± SD area under the plasma concentration-time over the dosing interval (AUCꞇ) was 37.1 ± 22.3 h*ng/mL.

The mean ± SD average plasma concentration (Cavg) was 3.1 ± 1.9 ng/mL.
[L15626]

Half-life

There is limited information on the half life of clascoterone.
[L15626]

Protein binding

Clascoterone is 84% to 89% bound to plasma proteins in vitro, regardless of drug concentrations.
[L15626]

Volume of distribution

There is no information available on the volume of distribution.

Metabolism

According to in vitro and clinical studies, the main possible primary metabolite of clascoterone is cortexolone, which is an inactive metabolite. The plasma concentrations of cortexolone were generally below or near the lower limit of quantitation (0.5 ng/mL).
[L15626]
Although clascoterone penetrates the skin, the systemic activity of the drug is limited due to rapid hydrolysis of clascoterone into the inactive metabolite by skin and plasma esterases,[A218761][A218846][A218861] namely carboxylesterase.
[A218851]

Route of elimination

Excretion of clascoterone has not been fully characterized in humans.
[L15626]
Upon topical application, clascoterone is quickly hydrolyzed in the epidermis.
[A218761]

Clearance

There is limited information on clearance of clascoterone.
[L15626]

Drug targets(1)

Proteins and enzymes this drug interacts with in the body

Androgen receptor

BE0000132

antagonist

Specific functionandrogen binding

Cellular location

Nucleus

General function & pharmacology

Steroid hormone receptors are ligand-activated transcription factors that regulate eukaryotic gene expression and affect cellular proliferation and differentiation in target tissues .
PMID:19022849
Transcription factor activity is modulated by bound coactivator and corepressor proteins like ZBTB7A that recruits NCOR1 and NCOR2 to the androgen response elements/ARE on target genes, negatively regulating androgen receptor signaling and androgen-induced cell proliferation .
PMID:20812024
Transcription activation is also down-regulated by NR0B2. Activated, but not phosphorylated, by HIPK3 and ZIPK/DAPK3

Metabolizing enzymes(8)

Enzymes involved in drug metabolism — important for understanding drug interactions

Enzyme activity key

substrate

inhibitor

inducer

CYP1A2Cytochrome P450 1A2

inhibitor

CYP2B6Cytochrome P450 2B6

inhibitor

CYP2C8Cytochrome P450 2C8

inhibitor

CYP2C9Cytochrome P450 2C9

inhibitor

CYP2C19Cytochrome P450 2C19

inhibitor

CYP2D6Cytochrome P450 2D6

inhibitor

CYP2E1Cytochrome P450 2E1

inhibitor

CYP3A4Cytochrome P450 3A4

inhibitor

Scientific references(8)

Hebert A., Thiboutot D., Stein Gold L., Cartwright M., Gerloni M., Fragasso E., Mazzetti A.

Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Apr 22. pii: 2765025. doi: 10.1001/jamadermatol.

2020

0465

Rosette C., Rosette N., Mazzetti A., Moro L., Gerloni M.

Data from The Dual Androgen Receptor and Glucocorticoid Receptor Antagonist CB-03-10 as Potential Treatment for Tumors that have Acquired GR-mediated Resistance to AR Blockade. doi: 10.1158/1535-7163.

6542800

PMID: 30811143 DOI: 10.1158/1535-7163.c.6542800

Rosette C., Agan F.J., Mazzetti A., Moro L., Gerloni M.

6542800

PMID: 31141847 DOI: 10.1158/1535-7163.c.6542800

Mazzetti A., Moro L., Gerloni M., Cartwright M.

Pharmacokinetic profile, safety, and tolerability of clascoterone topical cream 1% in subjects with moderate-to-severe acne vulgaris: An open-label phase IIa study.

Journal of the American Academy of Dermatology

201981(4):AB255. doi: 10.1016/j.jaad.2019.06.1127

PMID: 31251549 DOI: 10.1016/j.jaad.2019.06.1127

Eichenfield L., Hebert A., Gold L.S., Cartwright M., Fragasso E., Moro L., Mazzetti A.

Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris.

Journal American Academy Dermatology

2020 Aug83(2):477-485. doi: 10.1016/j.jaad.2020.04.087. Epub 2020 Apr 26

PMID: 32348828 DOI: 10.1016/j.jaad.2020.04.087

Pyo S.M., Maibach H.I.

Skin Metabolism: Relevance of Skin Enzymes for Rational Drug Design.

Skin Pharmacology Physiology

201932(5):283-294. doi: 10.1159/000501732. Epub 2019 Jul 29

PMID: 31357203 DOI: 10.1159/000501732

Tokudome Y., Katayanagi M., Hashimoto F.

Esterase Activity and Intracellular Localization in Reconstructed Human Epidermal Cultured Skin Models.

Ann Dermatology

2015 Jun27(3):269-74. doi: 10.5021/ad.2015.27.3.269. Epub 2015 May 29

PMID: 26082583 DOI: 10.5021/ad.2015.27.3.269

Ferraboschi P., Legnani L., Celasco G., Moro L., Ragonesi L., Colombo D.

A full conformational characterization of antiandrogen cortexolone-17α-propionate and related compounds through theoretical calculations and nuclear magnetic resonance spectroscopy.

Medicine

Chem. Commun.. 20145(7):904-914. doi: 10.1039/c4md00049h

DOI: 10.1039/c4md00049h

ATC classification(1 code)

ATC D10AX06

International brands(2)

Commercial products(2)

Chemical identifiers

CAS, UNII, InChI Key and database cross-references

Show

Linked compound data from DrugBank Open Data (CC BY-NC 4.0)

Clascoterone

DB12499

CAS number

19608-29-8

UNII (FDA)

XN7MM8XG2M

InChI Key (molecular fingerprint)

GPNHMOZDMYNCPO-PDUMRIMRSA-N

Additional database identifiers

Drugs Product Database (DPD)

23861

PubChem Compound

11750009

PubChem Substance

347828732

ChemSpider

9924713

Wikipedia

Clascoterone

ChEMBL

CHEMBL3590187

ZINC

ZINC000006716459

RxCUI

2474340

HUGO Gene Nomenclature Committee (HGNC)

HGNC:644

GenAtlas

GeneCards

GenBank Gene Database

M20132

GenBank Protein Database

178628

IUPHAR

628

Guide to Pharmacology

628

UniProtKB

P10275

UniProt Accession

ANDR_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2596

GenAtlas

CYP1A2

GeneCards

CYP1A2

GenBank Gene Database

Z00036

Guide to Pharmacology

1319

UniProtKB

P05177

UniProt Accession

CP1A2_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2615

GeneCards

CYP2B6

GenBank Gene Database

M29874

GenBank Protein Database

181296

Guide to Pharmacology

1324

UniProtKB

P20813

UniProt Accession

CP2B6_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2622

GenAtlas

CYP2C8

GeneCards

CYP2C8

GenBank Gene Database

M17397

Guide to Pharmacology

1325

UniProtKB

P10632

UniProt Accession

CP2C8_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2623

GenAtlas

CYP2C9

GeneCards

CYP2C9

GenBank Gene Database

AY341248

Guide to Pharmacology

1326

UniProtKB

P11712

UniProt Accession

CP2C9_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2621

GeneCards

CYP2C19

GenBank Gene Database

M61854

GenBank Protein Database

181344

Guide to Pharmacology

1328

UniProtKB

P33261

UniProt Accession

CP2CJ_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2625

GenAtlas

CYP2D6

GeneCards

CYP2D6

GenBank Gene Database

M20403

GenBank Protein Database

181350

Guide to Pharmacology

1329

UniProtKB

P10635

UniProt Accession

CP2D6_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2631

GeneCards

CYP2E1

GenBank Gene Database

J02625

GenBank Protein Database

181360

Guide to Pharmacology

1330

UniProtKB

P05181

UniProt Accession

CP2E1_HUMAN

HUGO Gene Nomenclature Committee (HGNC)

HGNC:2637

GenAtlas

CYP3A4

GeneCards

CYP3A4

GenBank Gene Database

M18907

Guide to Pharmacology

1337

UniProtKB

P08684

UniProt Accession

CP3A4_HUMAN

Patent information

7 active patents, 3 expired

8785427

United States

Approved 22 Jul 2014 · Expires 25 Jul 2030

4y 3m

9433628

United States

Approved 6 Sept 2016 · Expires 8 Feb 2029

2y 10m

11207332

United States

Approved 28 Dec 2021 · Expires 20 Nov 2028

2y 7m

10159682

United States

Approved 25 Dec 2018 · Expires 14 Aug 2028

2y 4m

9486458

United States

Approved 8 Nov 2016 · Expires 24 Jul 2028

2y 3m

Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.

DrugBank citations

If you use DrugBank data in your research, please cite the following publications:

Knox C., Wilson M., Klinger C.M., et al

DrugBank 6.

0: the DrugBank Knowledgebase for 2024

Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275

PMID: 37953279

Wishart D.S., Feunang Y.D., Guo A.C., et al

DrugBank 5.

0: a major update to the DrugBank database for 2018

Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082

PMID: 29126136

Show earlier publications

Law V., Knox C., Djoumbou Y., et al

DrugBank 4.

0: shedding new light on drug metabolism

Nucleic Acids Res. 2014 Jan 142(1):D1091-7

PMID: 24203711

Knox C., Law V., Jewison T., et al

DrugBank 3.

0: a comprehensive resource for 'omics' research on drugs

Nucleic Acids Res. 2011 Jan39(Database issue):D1035-41

PMID: 21059682

Wishart D.S., Knox C., Guo A.C., et al

DrugBank: a knowledgebase for drugs, drug actions and drug targets.

Nucleic Acids Research

2008 Jan36(Database issue):D901-6

PMID: 18048412

Wishart D.S., Knox C., Guo A.C., et al

DrugBank: a comprehensive resource for in silico drug discovery and exploration.

Nucleic Acids Research

2006 Jan 134(Database issue):D668-72

PMID: 16381955

Source: go.drugbank.comCC BY-NC 4.0

Updated 26 days ago(8 Mar 2026)

Back to medicines

Clascoterone 10mg/g cream

Prescription only

Requires a prescription from a doctor or prescriber

Cream

10mg

Topical

Creams, ointments & gels

Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors.

Active ingredients:

Clascoterone

BNF classificationBrowse formulary

Where this medicine sits in the British National Formulary — the UK's standard prescribing reference

BNF 13.06.01

ATC classificationBrowse ATC index

International classification by the WHO, grouping medicines by the organ system they act on

ATC D10AX06

Chemical classBrowse classes

Classification based on the molecule's chemical structure and properties

Check interactions for Clascoterone

No active safety alerts

Official documents, adverse reaction reporting, and safety monitoring

Report a side effect

Submit a Yellow Card report to the MHRA

Official medicine documents

Yellow Card

Report side effects (MHRA)

Drug safety updates

MHRA alerts for Clascoterone

Source: MHRA Products DatabaseOGL 3.0

Updated 3 months ago(16 Jan 2026)

Safety monitoring data

Yellow Card reports

MHRA

The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.

View Drug Analysis Profile

Browse all Drug Analysis Profiles A–Z

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Report a side effect

Submit a Yellow Card report to the MHRA

Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.

EudraVigilance

EMA

The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.

View EudraVigilance report

Suspected adverse reactions reported for Clascoterone

About EudraVigilance

Learn about EU pharmacovigilance and safety monitoring

EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.

1 branded products available

1 productsShow details

1 products

Possibly available on the UK marketDiscontinuedAvailability per NHS dm+d

MHRA licensed products

View all licensed products for Clascoterone on the MHRA register

Winlevi 10mg/g cream

Glenmark Pharmaceuticals Europe Ltd

Source: NHS dm+dOGL 3.0

Updated about 1 month ago(1 Mar 2026)

PriceShow details

£19.43indicative price

This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.

View full Drug Tariff

Source: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.

Therapeutically similar medicines

10 similarShow details

Resorcinol 50% in Glycerol

50%

Azelaic acid 15% gel

Gel

15%

Generic Actinac lotion

Aluminium oxide 52% paste

52%

Aluminium oxide 38% paste

38%

Drug monograph — bnf.nice.org.uk

Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.

NHS prescribing volume and spending trends

Show details

Loading prescribing data...

Clinical guidelines and formulary information

British National Formulary

Clascoterone

BNF

Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.

NICE clinical guidance(1)

Clascoterone for treating acne vulgaris in people 12 years and over (terminated appraisal) (TA1105)

TA1105

Technology appraisal

Updated Oct 2025

Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.

Check stock at pharmacies and supply information

Show details

Pharmacy stock checkers

Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.

Boots

Search products

Click & collectNHS

Lloyds

Search products

P2U

Pharmacy2U

Search products