Wednesday, July 8, 2026

Drug profile · INN

everolimus

everolimus (AFINITOR) is a fk506-binding protein 1a inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01XE10
US status approved
Patents linked 1
Pipeline programs 21
News articles 0
Drug details — everolimus
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
21
Data quality
0.89

Quick answer

everolimus (AFINITOR) is a fk506-binding protein 1a inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN everolimus
Brand AFINITOR
Mechanism FK506-binding protein 1A inhibitor
Target Peptidyl-prolyl cis-trans isomerase FKBP1A
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET, FOR SUSPENSION
ATC code L01XE10

Mechanism of action

FK506-binding protein 1A inhibitor

Primary target: Peptidyl-prolyl cis-trans isomerase FKBP1A

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Afinitor 2.5 mg tablets, Afinitor 10 mg tablets Phase 3 · George Institute for · Children, adolescents and adults with newly diagnosed diffus
  2. Afinitor 5 mg tablets, PLACEBO Phase 3 · Ningbo Cancer Hospital · Patients with high risk of relapse, ER+ and HER2- primary no
  3. C4391022 Phase 3 · First Biotech (Australia) · Hormone receptor-positive, her2-negative advanced/metastatic
  4. C4551002 Phase 3 · First Biotech (Australia) · Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic
  5. EVEROLIMUS Phase 3 · Novartis India · Refractory seizures associated with tuberous sclerosis compl
  6. Everolimus Phase 3 · United Therapeutics Europe · Pediatric Heart Transplantation
  7. Everolimus Phase 3 · Jazz Pharmaceuticals Ireland · Diffuse Intrinsic Pontine Glioma
  8. Everolimus Phase 3 · Novartis India · Advanced NET of GI Origin

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 12102619

    Methods of treating tuberous sclerosis complex with cannabidiol and everolimus

    Expires Mon Sep 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is everolimus?

everolimus (AFINITOR) is a fk506-binding protein 1a inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for everolimus?

AFINITOR is a marketed brand name for everolimus. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of everolimus?

everolimus has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.