Market atlas / mTOR inhibitors / Rapamycin

Rapamycin (sirolimus), longevity use

repurposedsmall-moleculemtor-inhibitionautophagyimmune-aging● il-6● epigenetic-clock

Stage by geography

Same development stage across markets, but Switzerland reached it about 21 years before Israel.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGILKRIN+1 stages

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 mTOR Inhibitor Immunosuppressant [EPC]; Kinase Inhibitor [EPC]
UK	approved	2001-03-13	indication This medicine is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is…
CN	approved	not dated	form Chemical drug
IN	real-world	not dated	not published
JP	approved	2014-07-04	indication A drug with a new active ingredient indicated for the treatment of lymphangioleiomyomatosis. [Orphan drug]
CH	approved	2000-09-26	indication Immunosuppressant
SG	approved	2002-07-27	form Tablet, sugar coated, oral, prescription only
IL	approved	2021-03-31	indication Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is…
KR	approved	2002-06-07	class Immunotherapy agents, incl. non-specific immunosuppressants [MFDS 01420]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20080120. Domestic generics vs imported originator.

13domestic approvals

Forms listed: 4
Product: Sirolimus
Origin: China
Approved: 2022-12-20
Approval no: NMPA H20080120

3imported approvals

approval count only; per-product detail not captured

Biomarker trends

PhenoAgeyears

77.38

▼ -3.96 years

Aging-206300

Studies

The studies on Rapamycin, 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
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	US
Change in IBM Functional Rating Scale (IBM-FRS) from Baseline to Week 84	US
Improved port wine stain fading/blanching after laser treatment	US
Maximum Tolerated Dose (MTD) of Irinotecan	US
Maximum Tolerated Dose (MTD) of Temsirolimus	US
Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants…	US
Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1).	US
Incidence of Treatment-Emergent Adverse Events	US
Clinical Activity	US
The Effect of Short-term Rapamycin Treatment on Biomarker Ki67 Associated With Progression to Invasive Breast Cancer	US

Connections

Trajectory

2000

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

Swissmedic:sirolimus (2000-09-26) · machine-extracted

2001

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

EMC:sirolimus (product 1368) · machine-extracted

2002

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

MFDS:sirolimus (2002-06-07) · machine-extracted

2002

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

HSA:sirolimus (2002-07-27) · machine-extracted

2014

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

PMDA:sirolimus (2014-07-04) · machine-extracted

2020

Relatedshares a mechanism with Everolimus

NCT04488601 · machine-extracted

2020

Relatedcontrasts with Metformin

NCT04488601 · machine-extracted

2020

ProfileRapamycin (sirolimus), longevity use

NCT04488601 · machine-extracted

2020

MarketUS: rct (in-trial)

NCT04488601 · machine-extracted

2021

MarketIL: approved-other (Israel MoH-registered)

IsraelMoH:sirolimus (2021-03-31) · machine-extracted

2023

BiomarkerPhenoAge at baseline in a low-dose rapamycin cohort

Aging-206300 · machine-extracted

2023

BiomarkerPhenoAge at end of study (net -3.96y vs +0.15y placebo)

Aging-206300 · machine-extracted

2026

MarketIN: real-world (generic-ubiquitous)

CDSCO-sirolimus · machine-extracted

2026

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

NCT00346918 · machine-extracted

2026

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

NCT00140543 · machine-extracted

2026

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

NCT00980460 · machine-extracted

2026

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

NCT05103358 · machine-extracted

2026

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

NCT00137345 · machine-extracted

2026

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

NMPA:NMPA H20080120 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA021083 · machine-extracted

Get into the weeds: raw observations + provenance

swissmedic__dev_rapamycin__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: sirolimusum (Rapamune 1 mg/ml, oral solution), first authorisation 2000-09-26. [Swissmedic list of authorised medicinal products]
   source Swissmedic:sirolimus (2000-09-26)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

rapa_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Rapamune 0.5mg coated tablets [active substance: sirolimus], first authorised 2001-03-13. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:sirolimus (product 1368)  https://www.medicines.org.uk/emc/product/1368/smpc

mfds__dev_rapamycin__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Sirolimus Dispersion Solution (RAPAMUNE TAB. 1MG), first approval 2002-06-07. [MFDS drug product-approval list]
   source MFDS:sirolimus (2002-06-07)  https://nedrug.mfds.go.kr/pbp/CCBGA01

hsa__dev_rapamycin__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: (Active Filler Coat) Sirolimus @ 100% (RAPAMUNE TABLET 1 mg), first registration 2002-07-27. [HSA Listing of Registered Therapeutic Products]
   source HSA:sirolimus (2002-07-27)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

pmda__dev_rapamycin__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Sirolimus (Rapalimus Tablets 1 mg (Nobelpharma Co., Ltd.)), first approval 2014-07-04. [PMDA List of Approved Drugs]
   source PMDA:sirolimus (2014-07-04)  https://www.pmda.go.jp/files/000281190.pdf

rapa_edge_evero  2026-06-29  kind=edge  verify=M
   shares mTOR mechanism
   source NCT04488601  https://clinicaltrials.gov/study/NCT04488601

rapa_edge_metf  2026-06-29  kind=edge  verify=M
   same goal, different pathway
   source NCT04488601  https://clinicaltrials.gov/study/NCT04488601

rapa_facets  2026-06-29  kind=facets  verify=M
   Rapamycin facets
   source NCT04488601  https://clinicaltrials.gov/study/NCT04488601

rapa_us  2026-06-29  kind=geography_stage  verify=M
   PEARL: low-dose rapamycin healthspan RCT (US)
   source NCT04488601  https://clinicaltrials.gov/study/NCT04488601

israelmoh__dev_rapamycin__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): SIROLIMUS 1 MG/ML (RAPAMUNE SOLUTION), current registration 2021-03-31. [Israel MoH Drug Registry]
   source IsraelMoH:sirolimus (2021-03-31)  https://israeldrugs.health.gov.il/

rapa_bm_pheno_0  2026-06-29  kind=biomarker_reading  verify=M
   PhenoAge at baseline in a low-dose rapamycin cohort
   source Aging-206300  https://www.aging-us.com/article/206300/text

rapa_bm_pheno_52  2026-06-29  kind=biomarker_reading  verify=M
   PhenoAge at end of study (net -3.96y vs +0.15y placebo)
   source Aging-206300  https://www.aging-us.com/article/206300/text

rapa_in  2026-06-29  kind=geography_stage  verify=M
   Sirolimus generic, decades of transplant dosing (India)
   source CDSCO-sirolimus  https://cdsco.gov.in/

ctsearch__CH__dev_rapamycin  2026-07-10  kind=geography_stage  verify=M
   sirolimus: 27 registered trial(s) in CH, highest phase 3 [NCT00346918]
   source NCT00346918  https://clinicaltrials.gov/study/NCT00346918

ctsearch__IL__dev_rapamycin  2026-07-10  kind=geography_stage  verify=M
   sirolimus: 4 registered trial(s) in IL, highest phase 3 [NCT00140543]
   source NCT00140543  https://clinicaltrials.gov/study/NCT00140543

ctsearch__JP__dev_rapamycin  2026-07-10  kind=geography_stage  verify=M
   sirolimus: 10 registered trial(s) in JP, highest phase 3 [NCT00980460]
   source NCT00980460  https://clinicaltrials.gov/study/NCT00980460

ctsearch__KR__dev_rapamycin  2026-07-10  kind=geography_stage  verify=M
   sirolimus: 28 registered trial(s) in KR, highest phase 2 [NCT05103358]
   source NCT05103358  https://clinicaltrials.gov/study/NCT05103358

ctsearch__SG__dev_rapamycin  2026-07-10  kind=geography_stage  verify=M
   sirolimus: 15 registered trial(s) in SG, highest phase 3 [NCT00137345]
   source NCT00137345  https://clinicaltrials.gov/study/NCT00137345

nmpa__dev_rapamycin__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (sirolimus): 13 domestic approval(s) (e.g. Sirolimus, China); 3 imported approval(s). Reference NMPA H20080120.
   source NMPA:NMPA H20080120  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA021083__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (SIROLIMUS); approved, marketed [NDA021083]
   source NDA021083  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021083