Overview
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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 2 | Recruiting | |||
2025/06/03 | Phase 1 | Not yet recruiting | Forward Pharmaceuticals Co., Ltd. | ||
2025/05/29 | Phase 1 | Not yet recruiting | Captor Therapeutics S.A. | ||
2025/04/24 | Phase 2 | Recruiting | |||
2025/04/24 | Phase 4 | Not yet recruiting | |||
2025/02/18 | Phase 1 | Not yet recruiting | |||
2025/01/23 | Phase 2 | Recruiting | |||
2024/12/10 | Phase 1 | Not yet recruiting | |||
2024/11/11 | Phase 1 | Not yet recruiting | Shanghai Runshi Pharmaceutical Technology Co., Ltd | ||
2024/11/08 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0628 | ORAL | 5 mg in 1 1 | 1/29/2016 | |
| Mylan Pharmaceuticals Inc. | 0378-0005 | ORAL | 2 mg in 1 1 | 3/10/2022 | |
| Natco Pharma Limited | 63850-0058 | ORAL | 2.5 mg in 1 1 | 6/8/2023 | |
| Biocon Pharma Inc. | 70377-010 | ORAL | 2.5 mg in 1 1 | 6/2/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0566 | ORAL | 5 mg in 1 1 | 1/29/2016 | |
| Novartis Pharmaceuticals Corporation | 0078-0626 | ORAL | 2 mg in 1 1 | 1/29/2016 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7766 | ORAL | 2.5 mg in 1 1 | 10/23/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-7769 | ORAL | 10 mg in 1 1 | 10/23/2023 | |
| Par Pharmaceutical, Inc. | 49884-160 | ORAL | 0.75 mg in 1 1 | 4/21/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0472 | ORAL | 0.75 mg in 1 1 | 9/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/2/2011 | ||
Authorised | 8/2/2009 | ||
Authorised | 9/2/2011 | ||
Authorised | 8/2/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CERTICAN TABLETS 0.5 MG | SIN13196P | TABLET | 0.5 MG | 4/18/2006 | |
| Afinitor Tablet 5mg | SIN13750P | TABLET | 5.00mg | 1/6/2010 | |
| CERTICAN TABLETS 0.25 MG | SIN13194P | TABLET | 0.25 MG | 4/18/2006 | |
| CERTICAN TABLETS 0.75 MG | SIN13195P | TABLET | 0.75 MG | 4/18/2006 | |
| Afinitor Tablet 10mg | SIN13749P | TABLET | 10.00mg | 1/6/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Everolimus Tablets | 国药准字H20253002 | 化学药品 | 片剂 | 1/2/2025 | |
| Everolimus Tablets | 国药准字H20253001 | 化学药品 | 片剂 | 1/2/2025 | |
| Everolimus Tablets | 国药准字H20253625 | 化学药品 | 片剂 | 3/18/2025 | |
| Everolimus Tablets | 国药准字H20253624 | 化学药品 | 片剂 | 3/18/2025 | |
| Everolimus Tablets | 国药准字HJ20171145 | 化学药品 | 片剂 | 3/30/2022 | |
| Everolimus Tablets | 国药准字H20234681 | 化学药品 | 片剂 | 12/26/2023 | |
| Everolimus Tablets | 国药准字HJ20150093 | 化学药品 | 片剂 | 8/1/2023 | |
| Everolimus Tablets | 国药准字HJ20171146 | 化学药品 | 片剂 | 3/30/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EVERCHEM TABLETS 2.5MG | N/A | N/A | N/A | 10/24/2024 | |
| EVERCHEM TABLETS 5MG | N/A | N/A | N/A | 10/24/2024 | |
| EVERCHEM TABLETS 10MG | N/A | N/A | N/A | 10/24/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TEVA-EVEROLIMUS everolimus 5 mg tablet blister pack | 277302 | Medicine | A | 4/20/2017 | |
| TEVA-EVEROLIMUS everolimus 10 mg tablet blister pack | 277304 | Medicine | A | 4/20/2017 | |
| CERTICAN everolimus 0.75mg tablet blister pack | 97509 | Medicine | A | 3/17/2005 | |
| AFINITOR everolimus 10 mg tablet blister pack | 154663 | Medicine | A | 8/6/2009 | |
| EVEROLIMUS-TEVA everolimus 10 mg tablet blister pack | 277287 | Medicine | A | 4/20/2017 | |
| CERTICAN everolimus 0.1mg dispersible tablet blister pack | 97520 | Medicine | A | 3/17/2005 | |
| CERTICAN everolimus 0.5mg tablet blister pack | 97506 | Medicine | A | 3/17/2005 | |
| EVEROLIMUS-TEVA everolimus 5 mg tablet blister pack | 277285 | Medicine | A | 4/20/2017 | |
| CERTICAN everolimus 1mg tablet blister pack | 97516 | Medicine | A | 3/17/2005 | |
| PHARMACOR EVEROLIMUS everolimus 0.5 mg tablet blister pack | 335143 | Medicine | A | 4/21/2021 |