Everolimus

Generic Name: Everolimus

Brand Names: Afinitor, Votubia, Zortress

Drug Type: Small Molecule

Chemical Formula: C_₅₃H_₈₃NO_₁₄

CAS Number: 159351-69-6

Unique Ingredient Identifier: 9HW64Q8G6G

Background: Everolimus is a derivative of Rapamycin (sirolimus), and works similarly to Rapamycin as an mTOR (mammalian target of rapamycin) inhibitor. It is currently used as an immunosuppressant to prevent rejection of organ transplants. In a similar fashion to other mTOR inhibitors Everolimus' effect is solely on the mTORC1 protein and not on the mTORC2 protein.

Indication: Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.

Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.

Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

Associated Conditions: Heart Transplant Rejection, Kidney Transplant Rejection, Liver Transplant Rejection, Progressive Neuroendocrine Tumors of pancreatic origin, Renal angiomyolipoma, tuberous sclerosis complex, Subependymal giant cell astrocytoma, tuberous sclerosis complex, Waldenstrom's Macroglobulinemia Refractory, Advanced Carcinoid tumor, Locally advanced Progressive Neuroendocrine Tumors of gastrointestinal origin, Locally advanced lung origin Progressive Neuroendocrine Tumors, Metastatic gastrointestinal origin Progressive Neuroendocrine Tumors, Metastatic lung origin Progressive Neuroendocrine Tumors, Refractory Advanced Renal Cell Carcinoma, Refractory, advanced Breast cancer, Unresectable gastrointestinal origin Progressive Neuroendocrine Tumors, Unresectable lung origin Progressive Neuroendocrine Tumors

Clinical Trials

Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

Phase 2

Not yet recruiting

Conditions: Pancreatic Neuroendocrine Tumor (pNET)
Extra-Pancreatic Neuroendocrine Tumor (epNET)

Interventions: Drug: Zanzalintinib
Drug: Everolimus

First Posted Date: 2025-04-24

Last Posted Date: 2025-04-24

Lead Sponsor: Exelixis

Target Recruit Count: 440

Registration Number: NCT06943755

Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

Phase 4

Not yet recruiting

Conditions: Heart Transplant

Interventions: Drug: Everolimus
Drug: Mycophenolate mofetil Tablet/Capsule

First Posted Date: 2025-04-24

Last Posted Date: 2025-04-24

Lead Sponsor: Chong Kun Dang Pharmaceutical

Target Recruit Count: 140

Registration Number: NCT06942156

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

EVR and EPO for Liver Transplant Tolerance

Phase 1

Not yet recruiting

Conditions: Liver Transplant

Interventions: Drug: Everolimus
Drug: Epoetin alfa

First Posted Date: 2025-02-18

Last Posted Date: 2025-03-14

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 20

Registration Number: NCT06832189

Locations: 🇺🇸
University of California San Francisco School of Medicine, San Francisco, California, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States

Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women

Phase 2

Recruiting

Conditions: Postmenopausal Women

Interventions: Other: Football Fitness Concept
Drug: Everolimus (Afinitor®)

First Posted Date: 2025-01-23

Last Posted Date: 2025-01-23

Lead Sponsor: Odense University Hospital

Target Recruit Count: 136

Registration Number: NCT06789900

Locations: 🇩🇰
Odense University Hospital, Odense, Denmark

MTOR Inhibitors in Older Adults

Phase 1

Not yet recruiting

Conditions: Aging

Interventions: Drug: Sirolimus 0.5 Mg Oral Tablet
Drug: Sirolimus 1Mg Oral Tablet
Drug: Sirolimus 2 MG Oral Tablet
Drug: Everolimus 0.5 MG Oral Tablet
Drug: Everolimus 1 MG Oral Tablet
Drug: Everolimus 2 MG Oral Tablet

First Posted Date: 2024-12-10

Last Posted Date: 2024-12-10

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 60

Registration Number: NCT06727305

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

Phase 1

Not yet recruiting

Conditions: Unresectable Locally Advanced or Metastatic Solid Tumors

Interventions: Drug: SYHA1813
Drug: Everolimus
Drug: SG001
Drug: Regorafenib
Drug: HB1801
Drug: Carboplatin
Drug: Cisplatin
Drug: Paclitaxel
Drug: Etoposide

First Posted Date: 2024-11-11

Last Posted Date: 2024-11-11

Lead Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

Target Recruit Count: 380

Registration Number: NCT06682611

A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE)

Phase 3

Recruiting

Conditions: Locally Advanced or Metastatic Breast Cancer

Interventions: Drug: Everolimus (Afinitor®)
Drug: SIM0270
Drug: Exemestane tablets
Drug: Fulvestrant injection

First Posted Date: 2024-11-08

Last Posted Date: 2024-12-04

Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Target Recruit Count: 460

Registration Number: NCT06680921

Locations: 🇨🇳
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, China
🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China