Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
WINLEVI vs ANDROID 10
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
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.
Androgen receptor agonist; testicular androgen responsible for development and maintenance of male sex characteristics and anabolic effects; increases protein synthesis and muscle mass.
FDA-approved for the topical treatment of acne vulgaris in patients aged 12 years and older.
Male hypogonadism (primary and hypogonadotropic),Delayed puberty in males,Off-label: Androgen replacement in transgender men (masculinizing hormone therapy)
WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.
Testosterone undecanoate 750 mg (3 m L) intramuscular injection every 10 weeks, or testosterone cypionate 50-400 mg intramuscular injection every 2-4 weeks. For gel formulations: 50-100 mg transdermally once daily.
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.
8 hours; clinical context: steady-state achieved in 2-3 days, dosing interval 8-12 hours.
Clascoterone is metabolized primarily by CYP3A4 and CYP2C8 to its major metabolite, cortexolone. It undergoes extensive first-pass metabolism if absorbed systemically.
Hepatic metabolism via CYP3A4; undergoes extensive first-pass metabolism; metabolites primarily excreted renally.
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.
Renal: 90% as glucuronide and sulfate conjugates, 6% as unchanged drug; fecal: 4%.
Approximately 72% bound to plasma proteins (mainly albumin and alpha-1-acid glycoprotein).
97-99% bound primarily to sex hormone-binding globulin (SHBG) and albumin.
Following intravenous administration, volume of distribution is approximately 1.8 L/kg, indicating extensive tissue distribution.
0.5-1.0 L/kg; indicates extensive distribution into tissues and organs.
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).
Oral: low (variable, ~5-20% due to first-pass metabolism); intramuscular: 100%.
No dosage adjustment required for renal impairment, as systemic absorption is minimal.
No specific dose adjustment required for renal impairment; monitor serum testosterone levels and clinical response. For severe renal impairment (GFR <30 m L/min), consider increased monitoring due to potential fluid retention.
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.
Contraindicated in patients with severe hepatic dysfunction (Child-Pugh class C). For mild to moderate impairment (Child-Pugh class A or B), use with caution and consider dose reduction; monitor liver function tests regularly.
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.
Not recommended for use in children; safety and efficacy not established. For delayed puberty in adolescent males: testosterone enanthate 50-200 mg intramuscularly every 2-4 weeks, titrated to response, with monitoring of bone age.
No specific dosage adjustment needed. However, elderly patients may have more sensitive skin; monitor for local irritation. Systemic exposure is minimal.
Start at low end of dosing range (e.g., testosterone cypionate 50 mg intramuscularly every 4 weeks or gel 25 mg daily) due to potential increased sensitivity and risk of prostatic hypertrophy or cardiovascular events. Monitor serum testosterone, hematocrit, and prostate-specific antigen (PSA).
None.
None
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.
Risk of hepatotoxicity; use with caution in patients with liver disease. Monitor liver function, lipid profile, and prostate-specific antigen (PSA). May cause fluid retention, gynecomastia, priapism, and sleep apnea. Not for use in women who are pregnant or breastfeeding. May accelerate growth of prostate cancer and benign prostatic hyperplasia. Androgenic effects may cause virilization in women.
Hypersensitivity to clascoterone or any component of the formulation.
Men with carcinoma of the prostate or breast; history of hypersensitivity to testosterone or any component; women who are pregnant or may become pregnant (risk of fetal harm); patients with severe hepatic or cardiac disease.
No specific food interactions are known. No dietary restrictions are required.
No known food interactions. However, methyltestosterone can increase appetite and cause weight gain; a balanced diet is recommended.
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.
Android 10 is a combination of methyltestosterone and ethinyl estradiol. Methyltestosterone is an androgen; exposure during pregnancy, particularly during the first trimester, can cause virilization of the female fetus. Ethinyl estradiol is contraindicated in pregnancy due to risk of fetal harm. Use is contraindicated in all trimesters.
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.
Methyltestosterone and ethinyl estradiol are excreted in breast milk. Methyltestosterone may cause virilization in female infants. Ethinyl estradiol may reduce milk production and quality. M/P ratio not available. Breastfeeding is contraindicated.
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.
Contraindicated in pregnancy; no dosing adjustments apply. If inadvertent use occurs, discontinue immediately.
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.
Android 10 is a brand name for methyltestosterone, an androgen and anabolic steroid. Use is restricted to replacement therapy in males with hypogonadism or delayed puberty due to androgen deficiency. Monitor liver function due to risk of peliosis hepatis and hepatocellular carcinoma. Contraindicated in males with breast or prostate cancer. Can cause erythrocytosis; monitor hematocrit. Discontinue if signs of virilization in women or priapism in men. Use caution in elderly due to increased risk of prostatic hypertrophy.
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.
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Report signs of liver problems: yellowing of skin or eyes, dark urine, light-colored stools, abdominal pain.,Notify your doctor if you experience swelling of ankles or feet, trouble breathing, or persistent erections lasting more than 4 hours.,May cause aggressive behavior, mood swings, or depression; contact your doctor if these occur.,Do not take if you are pregnant or breastfeeding.,Keep all appointments for blood tests and liver function monitoring.
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 WINLEVI vs ANDROID 10, answered by our medical review team.
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.. ANDROID 10 is a Androgen that works by Androgen receptor agonist; testicular androgen responsible for development and maintenance of male sex characteristics and anabolic effects; increases protein synthesis and muscle mass.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between WINLEVI and ANDROID 10 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 WINLEVI is: WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.. The standard adult dose of ANDROID 10 is: Testosterone undecanoate 750 mg (3 m L) intramuscular injection every 10 weeks, or testosterone cypionate 50-400 mg intramuscular injection every 2-4 weeks. For gel formulations: 50-100 mg transdermally once daily.. 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 WINLEVI and ANDROID 10 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. 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. ANDROID 10 is classified as Category C. Android 10 is a combination of methyltestosterone and ethinyl estradiol. Methyltestosterone is an androgen; exposure during pregnancy, particularly during the first trimester, can . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.