Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
Informational only. Not medical advice.INFORMATIONAL PLATFORM ONLY — NOT MEDICAL ADVICE, DIAGNOSIS, OR TREATMENT
Head-to-head comparison of Clascoterone (CB-03-01) and Enclomiphene — mechanism, side effects, legal status, and pricing.
Clascoterone is a non-peptide steroidal topical androgen receptor antagonist—a 17α-propionate ester of cortexolone (11-deoxycortisol). Winlevi (clascoterone 1% cream) is FDA-approved (2020) for topical treatment of acne vulgaris in patients 12 years and older. A higher-strength 5% topical solution (Breezula) has completed Phase 3 trials for male androgenetic alopecia but remains investigational for that indication. Despite established androgen-receptor binding, the FDA label states the mechanism of action for acne treatment is unknown.
Enclomiphene is the trans-stereoisomer of clomiphene citrate, a non-steroidal selective estrogen receptor modulator (SERM) that stimulates endogenous testosterone production. It is not a peptide, but is widely tracked in the peptide and TRT community as an off-label, compounded alternative to testosterone replacement therapy for men who wish to preserve fertility. Clomiphene itself is a ~60:40 mixture of enclomiphene (trans, estrogen-antagonist) and zuclomiphene (cis, weak long-acting estrogen-agonist); isolating the trans-isomer is intended to deliver the HPG-axis effect without the zuclomiphene-driven side effects.
Clascoterone (CB-03-01)
Enclomiphene
Category
Legal Status
Mechanism
Half-life
Side Effects
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Clascoterone (CB-03-01)
Enclomiphene
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Check Enclomiphene prices →COA corpus from Disclosed Labs — independently tested batches only.
Clascoterone (CB-03-01)
2
COAs
98.8%
Avg purity
2
Labs
Enclomiphene
3
COAs
99.6%
Avg purity
1
Labs
Clascoterone is an FDA-approved prescription drug. Winlevi (clascoterone 1% cream) was approved in 2020 for topical treatment of acne vulgaris in patients 12 years of age and older, based on two identical Phase 3 RCTs (NCT02608450, NCT02608476; n=1421, ages 12+) showing IGA success rates of 18.8% and 20.9% for clascoterone vs. 8.7% and 6.6% for vehicle at Week 12. A separate, higher-strength 5% topical solution (Breezula) has completed a Phase 3 trial (SCALP2, NCT05914805, actual enrollment 762) for male androgenetic alopecia; this indication is investigational/unapproved. In hamster flank-organ models (topical antiandrogen bioassay), CB-03-01 showed strong local antiandrogenic activity—roughly 4× more potent than progesterone, ~3× more potent than flutamide, ~2× more potent than finasteride, and approximately equipotent with cyproterone acetate (Celasco et al., 2004, PMID 15646372). In rat subcutaneous injection and parabiotic rat models, no systemic antiandrogenic activity was observed, supporting a peripherally-selective (non-systemic) antiandrogen profile (Celasco et al., 2004). In human primary sebocyte cultures (in vitro), clascoterone dose-dependently suppressed lipid synthesis and inflammatory cytokine production, significantly outperforming spironolactone at inhibiting inflammatory cytokine synthesis (Rosette et al., 2019, PMID 31141847).
Key references
Wiehle et al. (BJU Int 2013, PMID 23875626) established pharmacokinetics and demonstrated testosterone restoration to the normal range in men with secondary hypogonadism. Kaminetsky et al. (J Sex Med 2013, PMID 23530575) showed enclomiphene raised testosterone and sperm counts while testosterone gel suppressed gonadotropins and spermatogenesis. Phase 3 trials ZA-304 and ZA-305 (Kim et al., BJU Int 2016, PMID 26496621) confirmed efficacy in overweight/obese hypogonadal men with superior preservation of LH, FSH, and sperm counts versus AndroGel 1.62%. Despite these positive data, the FDA issued Complete Response Letters to Repros Therapeutics in 2014 and 2016; Androxal was never approved and Repros subsequently wound down. As of April 2026 no FDA-approved enclomiphene exists. It is dispensed off-label via 503A compounding pharmacies for secondary hypogonadism and post-TRT/HPTA restart.
Clascoterone (CB-03-01) (Cosmetic) and Enclomiphene (Hormone) are in different categories and target different biological pathways. This is a common pattern in multi-compound research protocols. Researchers should monitor the biomarkers from both profiles and watch for interactions listed in each compound’s contraindications. Consult a licensed healthcare provider before combining any research compounds.
This platform provides informational tools only, not medical advice. This comparison is for educational purposes only. Consult a licensed provider.
Contraindications
Lab Testing
Key references
Disclosed Labs