NDATOPICALGELPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
HYFTOR (sirolimus) by Hetero is mtor inhibitors [moa]. First approved in 2022.
Drug data last refreshed 26m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYFTOR is a topical gel formulation of sirolimus, an mTOR inhibitor immunosuppressant approved in March 2022. It is applied directly to skin and works by inhibiting the mTOR pathway to reduce immune-mediated inflammation. The product is used in dermatological conditions where localized immunosuppression is therapeutically beneficial.
$0.916MPart D
Peak18.4 years to LOEPeak lifecycle stage with modest Part D penetration suggests a mature but niche product with limited growth trajectory and likely small dedicated commercial team.
Mechanism of Action
mTOR Inhibitors
Pharmacologic Class:
mTOR Inhibitor Immunosuppressant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS
Started Dec 2026
150 enrolled
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Low-Dose Sirolimus for the Treatment of RUNX1 Familial Platelet Disorder
Started Oct 2026
6 enrolled
Familial Platelet Disorder With Associated Myeloid Malignancy
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Started Jul 2026
74 enrolled
SarcomaOsteosarcoma
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)
Started Apr 2026
15 enrolled
Angiokeratomas
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Started Apr 2026
478 enrolled
Popliteal Artery DiseaseSuperficial Femoral Artery Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.