Everolimus - PharmaKB

Afinitor(everolimus)

Afinitor, Everolimus, Votubia, Zortress (everolimus) is a small molecule pharmaceutical. Everolimus was first approved as Afinitor on 2009-03-30. It has been approved in Europe to treat breast neoplasms, pancreatic neoplasms, renal cell carcinoma, and tuberous sclerosis. The pharmaceutical is active against serine/threonine-protein kinase mTOR.

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Novartis Pharmaceuticals

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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
nervous system diseases	D009422
urogenital diseases	D000091642
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
endocrine system diseases	D004700

Trade Name

FDA

EMA

Afinitor, Afinitor disperz, Everolimus, Zortress (discontinued: Everolimus)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Everolimus

Tradename	Company	Number	Date	Products
AFINITOR	Novartis	N-022334 RX	2009-03-30	4 products, RLD
ZORTRESS	Novartis	N-021560 RX	2010-04-20	4 products, RLD
AFINITOR DISPERZ	Novartis	N-203985 RX	2012-08-29	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
afinitor	New Drug Application	2025-08-12
everolimus	ANDA	2050-01-01
torpenz	ANDA	2024-11-18
zortress	New Drug Application	2025-08-12

Indications

FDA

EMA

No data

Agency Specific

FDA

EMA

Expiration	Code
EVEROLIMUS, AFINITOR DISPERZ, NOVARTIS PHARM
2025-04-10	ODE-169
EVEROLIMUS, AFINITOR, NOVARTIS
2023-02-26	ODE-108

Patent Expiration

Patent	Expires	FDA Information
Everolimus, Afinitor, Novartis
9006224	2028-07-01	U-1681
8410131	2025-11-01	U-1368

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents

— L01EG: Mammalian target of rapamycin (mtor) kinase inhibitors

— L01EG02: Everolimus

— L04: Immunosuppressants

— L04A: Immunosuppressants

— L04AA: Selective immunosuppressants

— L04AA18: Everolimus

HCPCS

Code	Description
J7527	Everolimus, oral, 0.25 mg

Clinical

Clinical Trials

1193 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	13	34	8	3	7	60
Neoplasms	D009369	—	C80	23	14	1	3	1	39
Kidney transplantation	D016030	—	—	1	3	14	20	—	38
Renal cell carcinoma	D002292	EFO_0000376	—	13	20	1	3	4	37
Carcinoma	D002277	—	C80.0	9	25	2	3	2	37
Neuroendocrine tumors	D018358	EFO_1001901	D3A.8	11	11	3	3	2	28
Liver transplantation	D016031	EFO_0010682	—	—	1	11	2	1	14
Lung neoplasms	D008175	—	C34.90	10	2	—	1	—	13
Tuberous sclerosis	D014402	—	Q85.1	4	7	4	2	—	13
Neoplasm metastasis	D009362	EFO_0009708	—	6	6	1	1	—	12

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	6	6	1	—	—	11
Astrocytoma	D001254	EFO_0000271	—	2	5	1	—	—	7
Hepatocellular carcinoma	D006528	—	C22.0	3	4	1	—	—	6
Large b-cell lymphoma diffuse	D016403	—	C83.3	2	2	1	—	—	5
Carcinoid tumor	D002276	—	D3A.00	3	2	1	—	—	5
B-cell lymphoma	D016393	—	—	1	2	1	—	—	4
Stomach neoplasms	D013274	EFO_0003897	C16	1	2	1	—	—	4
Lymphangioleiomyomatosis	D018192	—	J84.81	2	3	1	—	—	4
Stomatitis	D013280	EFO_1001904	K12.1	—	2	1	—	—	3
Organ transplantation	D016377	—	—	—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Kidney neoplasms	D007680	EFO_0003865	C64	7	8	—	—	—	14
Non-small-cell lung carcinoma	D002289	—	—	8	1	—	—	—	9
Colorectal neoplasms	D015179	—	—	6	7	—	—	—	9
Recurrence	D012008	—	—	4	4	—	—	—	8
Prostatic neoplasms	D011471	—	C61	4	6	—	—	—	8
Head and neck neoplasms	D006258	—	—	5	5	—	—	—	8
Pancreatic neoplasms	D010190	EFO_0003860	C25	3	7	—	—	—	8
Sarcoma	D012509	—	—	2	4	—	—	—	6
Glioblastoma	D005909	EFO_0000515	—	3	4	—	—	—	6
Adenocarcinoma	D000230	—	—	3	5	—	—	—	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Esophageal neoplasms	D004938	—	C15	2	—	—	—	—	2
Multiple myeloma	D009101	—	C90.0	2	—	—	—	—	2
Uterine cervical neoplasms	D002583	—	—	2	—	—	—	—	2
Brain stem neoplasms	D020295	EFO_1001767	—	1	—	—	—	—	1
Plasma cell neoplasms	D054219	—	—	1	—	—	—	—	1
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	1	—	—	—	—	1
Follicular lymphoma	D008224	—	C82	1	—	—	—	—	1
Nasopharyngeal carcinoma	D000077274	—	—	1	—	—	—	—	1
Adenoid cystic carcinoma	D003528	—	—	1	—	—	—	—	1
Ureteral neoplasms	D014516	EFO_0003844	C66	1	—	—	—	—	1

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Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Everolimus
INN	everolimus
Description	Everolimus is a macrocyclic lactone that is rapamycin in which the hydroxy group attached to the cyclohexyl moiety has been converted into the corresponding 2-hydroxyethyl ether. It is an immunosuppressant and antineoplastic agent. It has a role as an antineoplastic agent, an immunosuppressive agent, a mTOR inhibitor, an anticoronaviral agent and a geroprotector. It is a primary alcohol, a secondary alcohol, an ether, a cyclic ketone, a cyclic acetal and a macrolide lactam. It is functionally related to a member of sirolimus.
Classification	Small molecule
Drug class	immunosuppressives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CO[C@H]1C[C@@H]2CC[C@@H](C)[C@@](O)(O2)C(=O)C(=O)N2CCCC[C@H]2C(=O)O[C@H]([C@H](C)C[C@@H]2CC[C@@H](OCCO)[C@H](OC)C2)CC(=O)[C@H](C)/C=C(\C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)/C=C/C=C/C=C/1C