Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
WINLEVI vs ANDROID 25
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.
Android 25 contains methyltestosterone, a synthetic androgen that binds to androgen receptors, promoting protein synthesis and anabolic effects. It also inhibits gonadotropin secretion from the pituitary, reducing endogenous testosterone production.
FDA-approved for the topical treatment of acne vulgaris in patients aged 12 years and older.
Hypogonadism in males (primary and secondary),Delayed puberty in males,Metastatic breast cancer in women (as palliative therapy)
WINLEVI (clascoterone) topical cream 1%: Apply a thin layer to the affected skin areas twice daily, in the morning and evening.
Testosterone 25 mg subcutaneously or intramuscularly every 2 to 4 weeks. Alternatively, 125 mg intramuscularly every 10 days.
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.
Terminal elimination half-life: 10–100 minutes (testosterone); clinical context: rapid clearance necessitates frequent dosing or use of esters for sustained effect
Clascoterone is metabolized primarily by CYP3A4 and CYP2C8 to its major metabolite, cortexolone. It undergoes extensive first-pass metabolism if absorbed systemically.
Primarily hepatic via reduction and oxidation; metabolites include androsterone and etiocholanolone; excreted in urine.
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, 5–10% unchanged); fecal/biliary: 10%
Approximately 72% bound to plasma proteins (mainly albumin and alpha-1-acid glycoprotein).
97–99% (sex hormone-binding globulin and albumin)
Following intravenous administration, volume of distribution is approximately 1.8 L/kg, indicating extensive tissue distribution.
0.3–0.6 L/kg; indicates distribution into lean muscle and sex 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: <5% (methyltestosterone: ~20–25% due to 17α-alkylation); IM: 100%
No dosage adjustment required for renal impairment, as systemic absorption is minimal.
No dose adjustment required for GFR ≥30 m L/min. For GFR <30 m L/min, consider reducing dose or increasing interval; monitor for fluid retention and hypertension.
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 Child-Pugh class B or C cirrhosis. For mild hepatic impairment (Child-Pugh A), start with lower dose (e.g., 12.5 mg every 2 weeks) and titrate based on response and liver function.
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 pediatric patients (safety and efficacy not established). For male adolescents with hypogonadism, individualize: start at 12.5 mg every 2 weeks and adjust based on testosterone levels and growth.
No specific dosage adjustment needed. However, elderly patients may have more sensitive skin; monitor for local irritation. Systemic exposure is minimal.
Start with lower initial dose (e.g., 12.5 mg every 2 weeks); monitor prostate-specific antigen (PSA) and hematocrit frequently. Avoid in patients with prostate cancer or untreated sleep apnea.
None.
WARNING: Androgens are contraindicated in pregnancy due to masculinization of female fetus. Hepatotoxicity, including peliosis hepatis and hepatic neoplasms, has been reported with prolonged use.
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.
Use with caution in patients with hepatic, renal, or cardiovascular disease; may cause gynecomastia, edema, hypercalcemia, and polycythemia; monitor liver function, lipid profile, and hematocrit periodically; may accelerate bone maturation in children; risk of prostate hypertrophy and urethral obstruction.
Hypersensitivity to clascoterone or any component of the formulation.
Known or suspected prostate cancer; male breast cancer; pregnancy; lactation; hypersensitivity to methyltestosterone; severe hepatic impairment.
No specific food interactions are known. No dietary restrictions are required.
Take with food containing fat (e.g., avocado, nuts, olive oil) to enhance absorption. Avoid grapefruit juice as it may increase testosterone levels via CYP3A4 inhibition. Limit alcohol due to potential liver 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 25 (methyltestosterone) is an androgen. First trimester: Virilization of female fetus, including clitoromegaly, labial fusion, urogenital sinus abnormalities if exposure occurs before 12 weeks gestation. Second and third trimesters: Continued risk of female pseudohermaphroditism, and potential for masculinization of female external genitalia. Androgens can cross the placenta and may also cause skeletal abnormalities and growth retardation. Pregnancy category X.
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 into breast milk; M/P ratio not established. May cause virilization in female infants and premature sexual development in male infants. Androgens can suppress lactation. Use during 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.
Android 25 is contraindicated in pregnancy, so no dosing adjustments are applicable. If used inadvertently, discontinue immediately. No pharmacokinetic data to guide dose changes; avoid use entirely.
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 25 (testosterone undecanoate) requires absorption via lymphatic system; administer with fat-containing meal. Monitor serum testosterone levels 3-5 hours post-dose. Avoid in patients with breast cancer or known or suspected prostate cancer. Risk of polycythemia; check hematocrit before and during therapy.
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 capsules with meals, especially those containing fat, to improve absorption.,Do not chew or crush capsules; swallow whole.,Report signs of deep vein thrombosis (leg swelling, pain) or pulmonary embolism (sudden dyspnea, chest pain).,Women of reproductive potential should avoid pregnancy; use effective contraception.,Keep out of reach of children; testosterone can cause serious harm if accidentally ingested.,Regular blood tests (testosterone, hematocrit, PSA, lipid profile) are required.
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 25, 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 25 is a Androgen that works by Android 25 contains methyltestosterone, a synthetic androgen that binds to androgen receptors, promoting protein synthesis and anabolic effects. It also inhibits gonadotropin secretion from the pituitary, reducing endogenous testosterone production.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between WINLEVI and ANDROID 25 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 25 is: Testosterone 25 mg subcutaneously or intramuscularly every 2 to 4 weeks. Alternatively, 125 mg intramuscularly every 10 days.. 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 25 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 25 is classified as Category C. Android 25 (methyltestosterone) is an androgen. First trimester: Virilization of female fetus, including clitoromegaly, labial fusion, urogenital sinus abnormalities if exposure oc. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.