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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FYARRO (sirolimus) is an intravenous mTOR inhibitor immunosuppressant approved by the FDA in November 2021. It is indicated for immunosuppression in transplant patients and other conditions requiring mTOR pathway inhibition. The drug works by binding to and inhibiting the mammalian target of rapamycin (mTOR), a key regulator of cell proliferation and immune response.
Peak14.5 years to LOE
Product is at peak commercial stage with potential for stable revenue; brand team likely maintaining steady-state operations without aggressive 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)
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
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
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
Started Feb 2026
41 enrolled
Epithelioid Hemangioendothelioma (EHE)
Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-based Conditioning With h-ATG, Radiation, and Sirolimus
Started Nov 2025
0Severe Combined Immune Deficiency (SCID)
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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.