NDAINTRAVENOUSPOWDERPriority Review
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
FYARRO (sirolimus) by Hetero is mtor inhibitors [moa]. First approved in 2021.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FYARRO (sirolimus) is an intravenous mTOR inhibitor immunosuppressant approved in November 2021 by Hetero. It is currently in peak lifecycle stage and is administered as an IV powder formulation. The drug works by inhibiting the mTOR pathway, which regulates cell growth and immune function.
Peak14.0 years to LOE
Product is in peak commercial stage with no listed direct competitors, but safety profile concerns (off-label use dominance, 397 reported deaths) and lack of Part D spending data suggest emerging commercial headwinds requiring focused medical and commercial strategy.
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.