NDATOPICALGELPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
HYFTOR (sirolimus) by Hetero is mtor inhibitors [moa]. First approved in 2022.
Drug data last refreshed 28m 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 indicated for dermatological conditions where localized immunosuppression is beneficial. The drug works by inhibiting mTOR signaling, reducing immune cell proliferation and activation at the site of application.
$0.916MPart D
Peak2.6 years to LOEEarly-stage peak lifecycle with modest Part D spending suggests a niche product with limited market penetration; commercial teams are likely focused on physician education and patient awareness expansion.
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)
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Started Jul 2026
74 enrolled
SarcomaOsteosarcoma
A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia
Started Apr 2026
216 enrolled
Autoimmune Hemolytic Anemia (AIHA)
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
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Started Feb 2026
41 enrolled
Epithelioid Hemangioendothelioma (EHE)
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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.