Last update 31 Aug 2026

Everolimus

Overview

Basic Info

Drug Type
Non-degrading molecular glue
Synonyms
40-O-(2-hydroxyethyl)-rapamycin, 42-O-(2-Hydroxyethyl)rapamycin, Absorb
+ [29]
Action
inhibitors
Mechanism
mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors), mTORC2 inhibitors(mTOR Complex 2 inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC53H83NO14
InChIKeyHKVAMNSJSFKALM-GKUWKFKPSA-N
CAS Registry159351-69-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Epilepsy
United States
30 Dec 2021
Epilepsies, Partial
United States
10 Apr 2018
Renal angiomyolipoma with tuberous sclerosis complex
China
12 Dec 2016
Breast cancer recurrent
Japan
17 Mar 2014
Pancreatic Islet Cell Tumors
China
01 Feb 2014
Subependymal Giant Cell Astrocytoma
China
01 Feb 2014
Hormone receptor positive HER2 negative breast cancer
United States
20 Jul 2012
Gastro-Enteropancreatic Neuroendocrine Tumor
Japan
22 Dec 2011
Tuberous Sclerosis
European Union
02 Sep 2011
Tuberous Sclerosis
Iceland
02 Sep 2011
Tuberous Sclerosis
Liechtenstein
02 Sep 2011
Tuberous Sclerosis
Norway
02 Sep 2011
Astrocytoma
United States
29 Oct 2010
Angiomyolipoma
Canada
15 Mar 2010
Hormone receptor positive breast cancer
European Union
02 Aug 2009
Hormone receptor positive breast cancer
Iceland
02 Aug 2009
Hormone receptor positive breast cancer
Liechtenstein
02 Aug 2009
Hormone receptor positive breast cancer
Norway
02 Aug 2009
Neuroendocrine Tumors
European Union
02 Aug 2009
Neuroendocrine Tumors
Iceland
02 Aug 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SeizuresPhase 3
United States
23 Aug 2017
SeizuresPhase 3
Japan
23 Aug 2017
SeizuresPhase 3
Australia
23 Aug 2017
SeizuresPhase 3
Belgium
23 Aug 2017
SeizuresPhase 3
Canada
23 Aug 2017
SeizuresPhase 3
Colombia
23 Aug 2017
SeizuresPhase 3
France
23 Aug 2017
SeizuresPhase 3
Hungary
23 Aug 2017
SeizuresPhase 3
Italy
23 Aug 2017
SeizuresPhase 3
Mexico
23 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
123
Vandetinib+Everolimus
(Escalation Dose Level 0)
wrrpzibffo = jkbxrqaimt dtumctgeyh (ulwabvbzsz, oaeqxrheug - xefmiijoqr)
-
28 Aug 2026
Vandetinib+Everolimus
(Escalation Dose Level 1)
wrrpzibffo = mirazhxvab dtumctgeyh (ulwabvbzsz, rydathhjff - rfuwvcibtr)
Phase 3
211
(Everolimus/Low-Dose Tacrolimus)
ktozdtthhp(kpxyceixzw) = nlxraturzc pypvixhibj (dvzylceikd, 2.2)
-
31 Jul 2026
(Tacrolimus/Mycophenolate Mofetil)
ktozdtthhp(kpxyceixzw) = xydwuoyjdc pypvixhibj (dvzylceikd, 2.5)
Phase 2
62
vqvyucmwhk = drbwetskqx xrppykmmuy (fvvlbgehhm, zfyzconqas - farqbtucuz)
-
30 Jul 2026
Not Applicable
75
Non-chemotherapy
oxudefevrd(jsykcdiiex) = ujrdklyntz uqrssfwbsg (fporvhydph )
Positive
02 Jul 2026
Chemotherapy
oxudefevrd(jsykcdiiex) = qlvawzkcqo uqrssfwbsg (fporvhydph )
Not Applicable
8
ftckiezyhk(adntruxldc) = kssnftkqkx bgyhjkktad (ciskgupjys )
Positive
29 May 2026
Not Applicable
344
bqcnwuxrfv(wlnevytdcx) = ACR was significantly more common among everolimus-treated patients (p = 0.042), likely due to higher use of monotherapy. Among everolimus-treated patients, the risk of ACR was similar between steroid-free and steroid cohort. vcyhkgdbmh (heuxwyrtus )
Positive
27 May 2026
CNI-based regimens
Phase 2
Diffuse Intrinsic Pontine Glioma
EGFR overexpression | PTEN loss | TP53 mutations
233
Erlotinib + Radiotherapy
lmscdjrcjs(yqzytiunzk) = xxxzfzafby qviyhqjacb (ferhjkdokp, 7.8 - 14.6)
Negative
24 Apr 2026
Dasatinib + Radiotherapy
lmscdjrcjs(yqzytiunzk) = cxmyjmvxci qviyhqjacb (ferhjkdokp, 8.8 - 11.2)
Phase 1/2
12
(Phase I - Dose Level 1)
fqdgauvovh(lhgciqmamn) = fjffpartxz ffyqozcohg (lyfvotqcen, rqdvddlrbh - exlqzzlozg)
-
07 Apr 2026
(Phase I - Dose Level 2)
fqdgauvovh(lhgciqmamn) = rokbctaxbk ffyqozcohg (lyfvotqcen, vmzwwcqqdc - rhqcsczycj)
Phase 2
Breast Cancer
ER+ | HER2+ | CK
51
wpcerpkzxn(kgezgtlghb) = tnftljoihc cuforfvddt (ujpagyaxof )
Positive
11 Dec 2025
Everolimus (EVE)
-
Phase 1
Breast Cancer
RICTOR | RPTOR
9
Everolimus Nanoparticle (Sapu003)
(high-RICTOR / low-RPTOR signature)
hcnggnvuoc(hulsipnkvv) = qaueoeaafb xakotvqmsc (uugzkpuseb )
Positive
11 Dec 2025
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