Market atlas / mTOR inhibitors / Temsirolimus

Temsirolimus (mTOR inhibitor)

repurposedsmall-moleculemtor-inhibition

Stage by geography

Same development stage across markets, but United Kingdom reached it about 3 years before Japan.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKJPKRCHSG+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	not published
UK	approved	2007-11-19	indication Renal cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of…
JP	approved	2010-07-23	indication A drug with a new active ingredient indicated for the treatment of unresectable or metastatic renal cell carcinoma.
CH	RCT	not dated	not published
SG	RCT	not dated	not published
KR	approved	2008-10-24	class Antineoplastic agents [MFDS 04210]

Biomarker trends

no biomarker readings yet

Studies

The studies on Temsirolimus, 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
Maximum Tolerated Dose (MTD) of Irinotecan	US
Maximum Tolerated Dose (MTD) of Temsirolimus	US
Toxicity. Number of Patients With Specific Toxicities Are Reported.	US
Best Response to Combination Treatment	US
Change in phosphorylation levels of other biomarkers before and after treatment	US
Change in phosphorylation levels of v-akt murine thymoma viral oncogene homolog 1 in terms of difference in IHC score	US
MTD of combination of cixutumumab and temsirolimus defined as the highest dose level at which no more than 1 of 6 evaluable…	US
Tumor metabolism as assessed by PET scan before and after treatment	US
Number of Patients That Experienced DLT During Cycle 1 of Therapy	US
Dose-limiting Toxicity (DLT) (Phase I)	US

Connections

Trajectory

2007

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

EMC:temsirolimus (product 6401) · machine-extracted

2008

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

MFDS:temsirolimus (2008-10-24) · machine-extracted

2009

Relatedshares a mechanism with Rapamycin

NCT01025453 · machine-extracted

2009

ProfileTemsirolimus (mTOR inhibitor)

NCT01025453 · machine-extracted

2009

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

NCT01025453 · machine-extracted

2010

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

PMDA:temsirolimus (2010-07-23) · machine-extracted

2026

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

NCT00474786 · machine-extracted

2026

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

NCT00980460 · machine-extracted

2026

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

NCT00474786 · machine-extracted

2026

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

NCT00474786 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA022088 · machine-extracted

Get into the weeds: raw observations + provenance

tems_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: TORISEL 30 mg concentrate and diluent for solution for infusion [active substance: temsirolimus], first authorised 2007-11-19. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:temsirolimus (product 6401)  https://www.medicines.org.uk/emc/product/6401/smpc

mfds__dev_temsirolimus__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Temsirolimus (TORISEL INJ), first approval 2008-10-24. [MFDS drug product-approval list]
   source MFDS:temsirolimus (2008-10-24)  https://nedrug.mfds.go.kr/pbp/CCBGA01

tems_edge_rapa  2026-06-29  kind=edge  verify=M
   both rapalog mTOR inhibitors
   source NCT01025453  https://clinicaltrials.gov/study/NCT01025453

tems_facets  2026-06-29  kind=facets  verify=M
   Temsirolimus facets
   source NCT01025453  https://clinicaltrials.gov/study/NCT01025453

tems_us_trial  2026-06-29  kind=geography_stage  verify=M
   Temsirolimus: US phase 2 trials [NCT01025453]
   source NCT01025453  https://clinicaltrials.gov/study/NCT01025453

pmda__dev_temsirolimus__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Temsirolimus (Torisel Injection 25 mg (Pfizer Japan Inc.)), first approval 2010-07-23. [PMDA List of Approved Drugs]
   source PMDA:temsirolimus (2010-07-23)  https://www.pmda.go.jp/files/000281190.pdf

ctsearch__CH__dev_temsirolimus  2026-07-10  kind=geography_stage  verify=M
   temsirolimus: 4 registered trial(s) in CH, highest phase 3 [NCT00474786]
   source NCT00474786  https://clinicaltrials.gov/study/NCT00474786

ctsearch__JP__dev_temsirolimus  2026-07-10  kind=geography_stage  verify=M
   temsirolimus: 4 registered trial(s) in JP, highest phase 3 [NCT00980460]
   source NCT00980460  https://clinicaltrials.gov/study/NCT00980460

ctsearch__KR__dev_temsirolimus  2026-07-10  kind=geography_stage  verify=M
   temsirolimus: 6 registered trial(s) in KR, highest phase 3 [NCT00474786]
   source NCT00474786  https://clinicaltrials.gov/study/NCT00474786

ctsearch__SG__dev_temsirolimus  2026-07-10  kind=geography_stage  verify=M
   temsirolimus: 2 registered trial(s) in SG, highest phase 3 [NCT00474786]
   source NCT00474786  https://clinicaltrials.gov/study/NCT00474786

openfda__NDA022088__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (TEMSIROLIMUS); approved, marketed [NDA022088]
   source NDA022088  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA022088