If you’re researching or seeking treatment for acne or hair loss, Clascoterone (CAS 19608-29-8) has likely piqued your interest. But with so many suppliers claiming to sell “FDA-approved” Clascoterone, how do you separate fact from fiction? This guide clarifies Clascoterone’s regulatory status, reveals where to buy the genuine FDA-approved formula, and provides actionable steps to avoid counterfeit products.
Is Clascoterone FDA-Approved?
Yes—Clascoterone Cream 1% is FDA-approved under the brand name Winlevi®. In August 2020, it became the first topical androgen receptor inhibitor approved for treating acne vulgaris in patients aged 12 and older. Key FDA approval highlights:
- Indication: Acne vulgaris (inflammatory and non-inflammatory lesions).
- Safety profile: Minimal systemic absorption, making it safer than oral anti-androgens.
- Prescription requirement: Available only through licensed healthcare providers in the U.S.
For researchers, Clascoterone (CAS 19608-29-8) is also available in bulk as a research chemical, but it’s labeled “For laboratory use only” and not for human consumption without proper approvals.
Why FDA Approval Matters
Purchasing FDA-approved Clascoterone ensures:
- Safety: Rigorous clinical trials confirm minimal side effects (e.g., mild redness or dryness).
- Efficacy: Proven to reduce acne lesions by 50–60% in 12-week studies.
- Quality control: Manufactured in GMP-certified facilities with batch consistency.
Non-FDA-approved versions (e.g., international generics or research chemicals) lack these guarantees, risking ineffective or harmful outcomes.
Where to Buy FDA-Approved Clascoterone Cream
Option 1: Retail Pharmacies (Winlevi®)
- Process: Obtain a prescription from a dermatologist or healthcare provider.
- Cost: 500–500–800 per tube without insurance; savings programs may reduce this to 25–25–100/month.
- Limitations: Not all pharmacies stock Winlevi®—call ahead to confirm availability.
Option 2: Research Suppliers (For Non-Clinical Use)
If you’re a researcher or compounding pharmacist, research-grade Clascoterone (CAS 19608-29-8) offers a cost-effective alternative. Ensure suppliers:
- Provide third-party purity testing (≥98% via HPLC).
- Follow GMP/ISO guidelines for production.
- Label products “Not for human use” to comply with regulations.
KiloBio’s Clascoterone meets these criteria, offering lab-grade Clascoterone with batch-specific COAs for verified quality.
3 Red Flags of Counterfeit Clascoterone
1. Missing FDA or GMP Credentials
Legitimate FDA-approved Clascoterone (Winlevi®) will always include:
- NDC number: Unique 10-digit identifier on packaging.
- Prescription requirement: No legitimate U.S. supplier sells Winlevi® without a script.
2. Suspiciously Low Prices
Authentic Winlevi® costs 500+pertube.Pricesbelow500+pertube.Pricesbelow200 likely indicate:
- Expired stock: Lost efficacy.
- Diluted formula: Contains less than 1% Clascoterone.
- Counterfeit packaging: Fake branding or CAS numbers.
3. Lack of Transparency
Avoid suppliers who:
- Refuse to share COAs or lab reports.
- Use vague terms like “anti-acne cream” without specifying Clascoterone.
- Operate via social media or unsecured websites.
Why Researchers Trust KiloBio for Clascoterone
For non-clinical applications, KiloBio’s Clascoterone (CAS 19608-29-8) is a top choice among labs and academic institutions:
- FDA-aligned manufacturing: Produced in facilities meeting 21 CFR Part 11 compliance.
- Unmatched purity: 99%+ verified by independent labs.
- Regulatory support: Includes MSDS sheets and customs documentation for global shipping.
- Bulk discounts: Save up to 40% on orders over 50g.
👉 Request a Quote for Research-Grade Clascoterone
FAQs About Buying FDA-Approved Clascoterone
Can I Buy Clascoterone Without a Prescription?
In the U.S., Winlevi® requires a prescription. Research-grade Clascoterone (CAS 19608-29-8) is available without a script but is not for human use.
Are Generic Versions FDA-Approved?
No. Patents protect Winlevi® until 2030. “Generic” Clascoterone sold online is unapproved and risky.
How to Verify Authenticity?
- Winlevi®: Check for NDC number 71205-013-60.
- Research-grade: Request a COA with batch-specific HPLC results.
Final Tips for a Safe Purchase
- Consult a Professional: Discuss Clascoterone with a dermatologist before use.
- Prioritize Transparency: Choose suppliers like KiloBio that disclose lab data and certifications.
- Report Suspicious Sellers: Alert the FDA or local authorities to counterfeit products.
Need Research-Grade Clascoterone?
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