Market atlas / mTOR inhibitors / Everolimus

Everolimus (RAD001), immune-aging

repurposedsmall-moleculemtor-inhibitionimmune-aging● immune-response

Stage by geography

Same development stage across markets, but Switzerland reached it about 17 years before Israel.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGILKR

MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS

What each market approved it for

Market	Stage	Since	Indication / class / form
US	approved	not dated	class Kinase Inhibitor [EPC]; mTOR Inhibitor Immunosuppressant [EPC]
UK	approved	2021-01-01	indication Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast…
CN	approved	not dated	form Tablet, chemical drug
JP	approved	2010-01-20	indication A drug with a new additional indication and a new dosage for the treatment of unresectable or metastatic renal cell carcinoma. [Priority review]
CH	approved	2005-04-21	indication Prophylaxis of organ rejection
SG	approved	2006-04-18	form Tablet, oral, prescription only
IL	approved	2021-12-30	indication Evetor is indicated for:- Treatment of patients with SEGA associated with tuberous sclerosis Complex (TSC) who require therapeutic intervention but are not…
KR	approved	2006-04-24	class Immunotherapy agents, incl. non-specific immunosuppressants [MFDS 01420]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20234681. Domestic generics vs imported originator.

6domestic approvals

Forms listed: 1
Product: Everolimus Tablets
Form: tablet
Strength: 2.5mg
Holder: Chia Tai Tianqing Pharmaceutical Group
Origin: China
Approved: 2023-12-26
Approval no: NMPA H20234681

2imported approvals

approval count only; per-product detail not captured

Biomarker trends

no biomarker readings yet

Studies

The studies on Everolimus, what they found, in whom and how strongly, are on its evidence page, each linked to its source.

What the trials measure

Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.

Registered primary endpoint	Markets measuring it
Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)	CH
MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR)	CH
Renal Function (Nankivell Formula) at Month 12 Post Transplantation.	CH
Percentage of Participants With Overall Response Rate (ORR)	IL
Target-lesion revascularization	JP
Death or myocardial infarction at 3-year after stent implantation	JP
Progression-free Survival (PFS)	KR
Progression free survival (PFS)	KR
Late luminal loss	KR
Neointimal coverage according to the implanted DES; Xience vs. Cypher	KR

Connections

no connections yet

Trajectory

2005

MarketCH: approved-other (Swissmedic-authorised (Switzerland))

Swissmedic:everolimus (2005-04-21) · machine-extracted

2006

MarketSG: approved-other (HSA-registered (Singapore))

HSA:everolimus (2006-04-18) · machine-extracted

2006

MarketKR: approved-other (MFDS-approved (South Korea))

MFDS:everolimus (2006-04-24) · machine-extracted

2010

MarketJP: approved-other (PMDA-approved (Japan))

PMDA:everolimus (2010-01-20) · machine-extracted

2010

ProfileEverolimus (RAD001), immune-aging

NDA021560 · machine-extracted

2021

MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)

EMC:everolimus (product 6658) · machine-extracted

2021

MarketIL: approved-other (Israel MoH-registered)

IsraelMoH:everolimus (2021-12-30) · machine-extracted

2026

MarketCH: rct (clinical trials (highest phase 2))

NCT00976755 · machine-extracted

2026

MarketIL: rct (clinical trials (highest phase 3))

NCT01035229 · machine-extracted

2026

MarketJP: rct (clinical trials (highest phase 3))

NCT01524783 · machine-extracted

2026

MarketKR: rct (clinical trials (highest phase 2))

NCT02344550 · machine-extracted

2026

MarketSG: rct (clinical trials (highest phase 3))

NCT01888432 · machine-extracted

2026

MarketCN: approved-other (NMPA-approved (domestic + imported))

NMPA:NMPA H20234681 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA021560 · machine-extracted

Get into the weeds: raw observations + provenance

swissmedic__dev_everolimus__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: everolimusum (Certican 0.5 mg, tablets), first authorisation 2005-04-21. [Swissmedic list of authorised medicinal products]
   source Swissmedic:everolimus (2005-04-21)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

hsa__dev_everolimus__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: EVEROLIMUS (CERTICAN TABLETS 0.5 MG), first registration 2006-04-18. [HSA Listing of Registered Therapeutic Products]
   source HSA:everolimus (2006-04-18)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

mfds__dev_everolimus__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Everolimus (CERTICAN TAB. 0.25MG), first approval 2006-04-24. [MFDS drug product-approval list]
   source MFDS:everolimus (2006-04-24)  https://nedrug.mfds.go.kr/pbp/CCBGA01

pmda__dev_everolimus__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Everolimus (Afinitor Tablets 5 mg (Novartis Pharma K.K.)), first approval 2010-01-20. [PMDA List of Approved Drugs]
   source PMDA:everolimus (2010-01-20)  https://www.pmda.go.jp/files/000281190.pdf

evero_facets  2026-06-29  kind=facets  verify=M
   Everolimus facets
   source NDA021560  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021560

evero_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Afinitor 10mg tablets [active substance: everolimus], first authorised 2021-01-01. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:everolimus (product 6658)  https://www.medicines.org.uk/emc/product/6658/smpc

israelmoh__dev_everolimus__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): EVEROLIMUS 10 MG (EVETOR 10), current registration 2021-12-30. [Israel MoH Drug Registry]
   source IsraelMoH:everolimus (2021-12-30)  https://israeldrugs.health.gov.il/

ctsearch__CH__dev_everolimus  2026-07-10  kind=geography_stage  verify=M
   everolimus: 43 registered trial(s) in CH, highest phase 2 [NCT00976755]
   source NCT00976755  https://clinicaltrials.gov/study/NCT00976755

ctsearch__IL__dev_everolimus  2026-07-10  kind=geography_stage  verify=M
   everolimus: 19 registered trial(s) in IL, highest phase 3 [NCT01035229]
   source NCT01035229  https://clinicaltrials.gov/study/NCT01035229

ctsearch__JP__dev_everolimus  2026-07-10  kind=geography_stage  verify=M
   everolimus: 37 registered trial(s) in JP, highest phase 3 [NCT01524783]
   source NCT01524783  https://clinicaltrials.gov/study/NCT01524783

ctsearch__KR__dev_everolimus  2026-07-10  kind=geography_stage  verify=M
   everolimus: 75 registered trial(s) in KR, highest phase 2 [NCT02344550]
   source NCT02344550  https://clinicaltrials.gov/study/NCT02344550

ctsearch__SG__dev_everolimus  2026-07-10  kind=geography_stage  verify=M
   everolimus: 12 registered trial(s) in SG, highest phase 3 [NCT01888432]
   source NCT01888432  https://clinicaltrials.gov/study/NCT01888432

nmpa__dev_everolimus__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (everolimus): 6 domestic approval(s) (e.g. Everolimus Tablets, 2.5mg, Chia Tai Tianqing Pharmaceutical Group, China); 2 imported approval(s). Reference NMPA H20234681.
   source NMPA:NMPA H20234681  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA021560__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (EVEROLIMUS); approved, marketed [NDA021560]
   source NDA021560  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021560