Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ANDROID 5 vs WINLEVI
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Androgen receptor agonist; stimulates protein synthesis and growth of androgen-sensitive tissues.
WINLEVI (clascoterone) is a topical androgen receptor inhibitor. It binds to the androgen receptor, preventing androgen-mediated signaling in sebocytes and inflammatory cells, thereby reducing sebum production and inflammation.
Testosterone replacement therapy for male hypogonadism,Off-label: delayed puberty in males
FDA-approved for the topical treatment of acne vulgaris in patients aged 12 years and older.
2.5-10 mg orally once daily in the morning for androgen replacement therapy in adult males.
WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.
Terminal elimination half-life is 3.5–5.5 hours; clinical effects may persist for several days due to active metabolites.
Terminal elimination half-life is approximately 7.3 hours following topical application of clascoterone 1% cream. This supports twice-daily dosing for maintaining therapeutic drug levels.
Hepatic via CYP3A4 and CYP2B6; undergoes first-pass metabolism.
Clascoterone is metabolized primarily by CYP3A4 and CYP2C8 to its major metabolite, cortexolone. It undergoes extensive first-pass metabolism if absorbed systemically.
Primarily renal: ~90% as glucuronide and sulfate conjugates, 6% as unchanged drug; ~5% fecal via bile.
Primarily fecal (approximately 84% of the dose) and renal (approximately 2.5% of the dose) following intravenous administration. Unchanged drug accounts for less than 1% in urine and feces.
98% bound to sex hormone-binding globulin (SHBG) and albumin.
Approximately 72% bound to plasma proteins (mainly albumin and alpha-1-acid glycoprotein).
Vd approximately 1.0 L/kg; indicates extensive tissue distribution, especially to reproductive organs and bone marrow.
Following intravenous administration, volume of distribution is approximately 1.8 L/kg, indicating extensive tissue distribution.
Oral: 15–25% due to first-pass metabolism; buccal or transdermal: higher, but not commercially available for this formulation.
Systemic bioavailability is minimal after topical application of clascoterone 1% cream, with plasma concentrations typically below the limit of quantitation; the exact percentage is not determined, but systemic exposure is negligible (<1% of applied dose).
No specific dose adjustment required based on GFR; caution in severe impairment (Cr Cl <30 m L/min) due to potential fluid retention.
No dosage adjustment required for renal impairment, as systemic absorption is minimal.
Contraindicated in Child-Pugh class B and C cirrhosis due to hepatotoxicity risk; in class A, use with caution and monitor liver function.
No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution.
Not recommended for use in children as it may cause premature epiphyseal closure and virilization; limited data.
Approved for patients aged 12 years and older. Same dosing as adults: apply a thin layer of 1% cream twice daily to affected areas. Safety and efficacy in children under 12 years have not been established.
Increased risk of prostatic hyperplasia and carcinoma; use lowest effective dose with regular prostate monitoring.
No specific dosage adjustment needed. However, elderly patients may have more sensitive skin; monitor for local irritation. Systemic exposure is minimal.
Warning: Prolonged use may cause virilization in women, premature epiphyseal closure, and increased risk of prostatic hypertrophy/carcinoma.
None.
Monitor liver function, lipid profile, and prostate-specific antigen; risk of edema in patients with cardiac disease; avoid use in patients with sleep apnea.
Local skin reactions including erythema, pruritus, and scaling may occur. Avoid contact with eyes, mouth, and mucous membranes. Not for oral, ophthalmic, or intravaginal use. Discontinue if signs of systemic toxicity or hypersensitivity develop. Use in pregnancy only if clearly needed; no adequate and well-controlled studies exist.
Known or suspected prostate cancer; breast cancer in males; hypersensitivity to androgens; pregnancy and lactation.
Hypersensitivity to clascoterone or any component of the formulation.
Avoid grapefruit and grapefruit juice as they may increase drug levels. Limit salt intake to reduce fluid retention. Alcohol may increase risk of liver toxicity.
No specific food interactions are known. No dietary restrictions are required.
Pregnancy Category X. ANDROID 5 (oxandrolone) is contraindicated in pregnancy due to teratogenic effects including masculinization of female fetus, clitoral enlargement, and labial fusion. Risk is highest during first trimester but applies throughout gestation.
WINLEVI (clascoterone) is a topical androgen receptor inhibitor. No adequate and well-controlled studies in pregnant women. In animal reproduction studies, no evidence of fetal harm was observed following topical administration of clascoterone during organogenesis at doses up to 2.5 mg/kg/day in rats (systemic exposure ~27 times the MRHD based on AUC) and 50 mg/kg/day in rabbits (systemic exposure 4 times the MRHD). However, because systemic absorption is minimal, the risk is considered low. Per FDA labeling, use during pregnancy only if clearly needed. No known fetal risks by trimester; avoid use on large areas of broken skin.
Excretion into human milk is unknown. Due to potential for androgenic effects in nursing infants, breastfeeding is not recommended. No M/P ratio available.
It is not known whether clascoterone is excreted in human milk after topical application. Systemically absorbed clascoterone is minimal; however, it is lipophilic and may partition into breast milk. No M/P ratio is available. Due to potential for serious adverse reactions in nursing infants, advise patients to avoid application to the breast area and to discontinue nursing or drug, taking into account importance of drug to mother.
Not applicable; contraindicated in pregnancy. No dose adjustment recommendations exist for pregnant patients.
No dose adjustment required in pregnancy due to minimal systemic absorption and lack of pharmacokinetic changes reported. Use with caution for acne treatment during pregnancy; weigh benefit vs risk. Apply thin layer once daily; avoid use on large areas of damaged skin.
Android 5 (methyltestosterone) is an androgenic anabolic steroid used for hypogonadism and delayed puberty. Monitor liver function due to hepatotoxicity. Use with caution in elderly due to increased risk of prostatic hypertrophy and carcinoma. Can cause fluid retention in patients with cardiac, renal, or hepatic disease. Avoid in patients with breast cancer or known or suspected prostate cancer.
WINLEVI (clascoterone) is a topical androgen receptor inhibitor approved for acne vulgaris. Avoid use on broken or eczematous skin. Monitor for signs of hyperkalemia in patients with renal impairment or those taking medications affecting potassium. Application should be limited to 1 gram per day (approximately 4 pump actuations) to minimize systemic absorption. Can be used in conjunction with other topical acne therapies but may require adjustment of irritation potential.
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Report any signs of liver problems: yellowing of skin or eyes, dark urine, severe stomach pain.,Women should report any signs of virilization: hoarseness, acne, menstrual changes, growth of facial hair.,Men should report any breast enlargement, changes in urination, or priapism.,Avoid driving or operating machinery if you experience dizziness or drowsiness.,Do not use if you are pregnant or planning to become pregnant.
Apply a thin layer to clean, dry skin once daily in the morning or evening as directed.,Do not apply to broken, cut, or sunburned skin.,Avoid contact with eyes, lips, and mucous membranes; if contact occurs, rinse with water.,Use sunscreen and protective clothing as WINLEVI may increase sun sensitivity.,Inform your doctor if you have kidney problems or are taking potassium-sparing diuretics or ACE inhibitors due to risk of hyperkalemia.,Do not use more than the prescribed amount; overdose can lead to systemic androgen blockade.,Store at room temperature (20°C-25°C) and keep out of reach of children.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about ANDROID 5 vs WINLEVI, answered by our medical review team.
ANDROID 5 is a Androgen that works by Androgen receptor agonist; stimulates protein synthesis and growth of androgen-sensitive tissues.. WINLEVI is a Topical Androgen Receptor Inhibitor that works by WINLEVI (clascoterone) is a topical androgen receptor inhibitor. It binds to the androgen receptor, preventing androgen-mediated signaling in sebocytes and inflammatory cells, thereby reducing sebum production and inflammation.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ANDROID 5 and WINLEVI depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of ANDROID 5 is: 2.5-10 mg orally once daily in the morning for androgen replacement therapy in adult males.. The standard adult dose of WINLEVI is: WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between ANDROID 5 and WINLEVI in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. ANDROID 5 is classified as Category C. Pregnancy Category X. ANDROID 5 (oxandrolone) is contraindicated in pregnancy due to teratogenic effects including masculinization of female fetus, clitoral enlargement, and labial. WINLEVI is classified as Category C. WINLEVI (clascoterone) is a topical androgen receptor inhibitor. No adequate and well-controlled studies in pregnant women. In animal reproduction studies, no evidence of fetal har. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.