Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
WINLEVI vs ANDROID-F
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.
Fingolimod is a sphingosine 1-phosphate receptor modulator that sequesters lymphocytes in lymph nodes, reducing central nervous system immune cell infiltration.
FDA-approved for the topical treatment of acne vulgaris in patients aged 12 years and older.
Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.
Adults: 1 tablet (methyltestosterone 2.5 mg, ethinyl estradiol 0.025 mg) orally once daily, with food.
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.
2.5-3.5 hours (terminal half-life); oral administration may require multiple daily doses for stable levels.
Clascoterone is metabolized primarily by CYP3A4 and CYP2C8 to its major metabolite, cortexolone. It undergoes extensive first-pass metabolism if absorbed systemically.
Metabolized primarily by CYP4F2, with minor contributions from CYP2D6, CYP2E1, CYP3A4, and CYP1A2. Undergoes biotransformation to an inactive metabolite.
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.
Primarily renal (90% as glucuronide and sulfate conjugates, 10% unchanged); small amount biliary/fecal.
Approximately 72% bound to plasma proteins (mainly albumin and alpha-1-acid glycoprotein).
97-99% bound to sex hormone-binding globulin (SHBG) and albumin.
Following intravenous administration, volume of distribution is approximately 1.8 L/kg, indicating extensive tissue distribution.
0.5-0.8 L/kg; reflects distribution into muscle, liver, and reproductive tissues.
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: 3-6% (extensive first-pass metabolism); IM: 100%.
No dosage adjustment required for renal impairment, as systemic absorption is minimal.
GFR 10-50 m L/min: reduce dose by 50%. GFR <10 m L/min: avoid use.
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.
Child-Pugh A: reduce dose by 50%. Child-Pugh B: avoid use. Child-Pugh C: contraindicated.
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 due to risk of premature epiphyseal closure and virilization.
No specific dosage adjustment needed. However, elderly patients may have more sensitive skin; monitor for local irritation. Systemic exposure is minimal.
Use with caution; consider lower starting dose due to increased risk of fluid retention, hypertension, and prostatic hypertrophy in males.
None.
Risk of bradyarrhythmia and atrioventricular block, requiring first-dose monitoring for 6 hours. Fatal infections, including opportunistic infections, have occurred. Macular edema has been reported.
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.
May cause bradycardia and AV block; monitor heart rate after first dose. Increased risk of infections, including herpes viruses and cryptococcal meningitis. Macular edema, especially in patients with diabetes or uveitis. Posterior reversible encephalopathy syndrome (PRES). Respiratory effects, including decreased FEV1 and DLCO. Hepatic injury; monitor liver enzymes.
Hypersensitivity to clascoterone or any component of the formulation.
Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure, history of Mobitz type II 2nd or 3rd degree AV block, sick sinus syndrome unless pacemaker is present, or severe untreated sleep apnea.
No specific food interactions are known. No dietary restrictions are required.
No significant food interactions reported. Avoid excessive alcohol consumption due to hepatotoxic effects.
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-F contains methyltestosterone, a synthetic androgen. Androgens are teratogenic in humans. In first trimester: masculinization of female fetus, including clitoromegaly, labial fusion, and urogenital sinus abnormalities. Second and third trimesters: continued virilization of female fetus; no increased risk of malformations in male fetuses. Contraindicated in pregnancy.
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 is excreted in breast milk. No specific M/P ratio available. May cause virilization in female infants and precocious development in male infants. Breastfeeding is contraindicated during therapy.
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-F is contraindicated in pregnancy; no dosing recommendations for use in pregnancy. No established dose adjustments exist as the drug should not be administered.
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-F is a brand of methyltestosterone, an androgen used primarily for male hypogonadism. Monitor liver function due to potential hepatotoxicity. Avoid in males with breast or prostate cancer. Use with caution in older patients due to increased risk of prostatic hypertrophy. May suppress clotting factors II, V, VII, and X.
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.,Report any signs of liver problems (yellowing eyes/skin, dark urine, persistent nausea) immediately.,Women should report hoarseness, acne, or menstrual changes.,Men should report frequent or persistent erections, or breast swelling/tenderness.,May cause decreased sperm count in men; discuss family planning.,Avoid concurrent use with other medications without consulting doctor.
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-F, 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-F is a Androgen/Estrogen Combination that works by Fingolimod is a sphingosine 1-phosphate receptor modulator that sequesters lymphocytes in lymph nodes, reducing central nervous system immune cell infiltration.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between WINLEVI and ANDROID-F 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-F is: Adults: 1 tablet (methyltestosterone 2.5 mg, ethinyl estradiol 0.025 mg) orally once daily, with food.. 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-F 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-F is classified as Category C. ANDROID-F contains methyltestosterone, a synthetic androgen. Androgens are teratogenic in humans. In first trimester: masculinization of female fetus, including clitoromegaly, labi. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.