503Pharma Intel Brief | January 2026

Hey there,

Something new for you today.

We've been thinking about how to make these emails more valuable—not just industry news, but data you can actually use.

Starting now, we are adding two sections: Clinical Trial Watch (what's being studied that could drive future compounding demand) and Medicare Coverage Updates -Local Coverage Determinants (LCD) and National Coverage Determinants (NCD) changes real effective dates.

This is the first edition. Reply and let us know if it's useful.

503Pharma Team

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🔬 Clinical Trial Watch

What's being studied today often signals what prescribers will want compounded tomorrow. Here's what caught our attention this month:

Topical Ketotifen for Vulvodynia (NCT07257029)

Status: Recruiting January 2026 Sponsor: Center for Vulvovaginal Disorders What: Phase 2 trial testing compounded ketotifen fumarate 0.25% cream for secondary vestibulodynia

Why it matters: If this trial shows efficacy, expect increased demand for topical ketotifen formulations from OB/GYN and pelvic pain specialists. Currently 54 patients enrolled across 3 sites.

View trial details →

Compounded Topical Anesthetics (NCT06569537)

Status: Actively recruiting Sponsor: Dartmouth-Hitchcock Medical Center What: Phase 4 trial comparing compounded BLT (benzocaine-lidocaine-tetracaine) cream vs standard lidocaine for procedural pain during IPL, pulse dye laser, and microneedling

Why it matters: Head-to-head comparison of compounded vs. commercial topical anesthetics. Positive results would give you clinical evidence to share with dermatology and aesthetics practices.

View trial details →

Micronized Progesterone vs. Synthetic Progestins (NCT05586724)

Status: Actively recruiting (520 patients) Sponsor: Karolinska Institute, Sweden What: Phase 3 trial comparing safety of oral micronized progesterone vs norethisterone acetate for menopausal hormone therapy

Why it matters: This is a large, rigorous trial that could strengthen the evidence base for bioidentical progesterone. Results expected late 2026—watch this space.

View trial details →

By the Numbers

Translation: Ketamine and GLP-1s continue to dominate clinical research. If you're not offering ketamine formulations yet, the evidence base is growing fast.

🏥 Medicare Coverage Updates

Note: If you do sterile compounding, infusion services, or work with facilities that bill Part B—these updates matter.

LCD Updates This Week

What Changed

Botulinum Toxin (L39909, L39832): Updated coverage criteria and billing guidance effective February 22. If you compound Botox alternatives, review before the effective date.

View LCD L39909 →

Implantable Infusion Pumps (A55239): New billing article for chronic pain management. Affects intrathecal compounds (morphine, baclofen).

View Article A55239 →

That's it for this edition.

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