Last update 04 Nov 2024

Repotrectinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Repotrectinib (USAN), Ropotrectinib, 洛普替尼
+ [11]
Mechanism
ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), TrkA antagonists(Nerve growth factor receptor Trk-A antagonists), TrkB inhibitors(Neurotrophic tyrosine kinase receptor type 2 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Conditional marketing approval (CN), Priority Review (US), Accelerated Approval (US), Priority Review (CN), Fast Track (US)
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Structure

Molecular FormulaC18H18FN5O2
InChIKeyFIKPXCOQUIZNHB-UHFFFAOYSA-N
CAS Registry1802220-02-5

External Link

KEGGWikiATCDrug Bank
D11454---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
NTRK fusion-positive solid tumors
US
13 Jun 2024
Reactive oxygen species 1 positive non-small cell lung cancer
US
15 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
KRAS G12D mutation Solid TumorsPhase 2
US
23 Sep 2021
KRAS mutation-related tumorsPhase 2
US
23 Sep 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
CN
10 May 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
CN
10 May 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
HK
10 May 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
HK
10 May 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
TW
10 May 2021
NTRK fusion-positive Non-small Cell Lung CancerPhase 2
TW
10 May 2021
Central Nervous System NeoplasmsPhase 2
US
12 Mar 2020
Central Nervous System NeoplasmsPhase 2
AU
12 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
127
(ROS1 Inhibitor Naïve Patients)
ynptnlmfas(utdpcxvkfz) = xnbezlirpw svfsfbiftx (aulrlkcfej, 68 - 88)
Positive
13 Jun 2024
(ROS1 Inhibitor Pretreated Patients)
ynptnlmfas(utdpcxvkfz) = uzheguerla svfsfbiftx (aulrlkcfej, 25 - 52)
Phase 1/2
NTRK fusion-positive solid tumors
NTRK gene fusion-positive
88
(TKI-Naïve Patients)
lwqzaqrsjj(mujxtsjhkl) = ukxscbdzcs ymwnbmtqgl (qamhwdvvii, 41 - 73)
Positive
13 Jun 2024
(TKI-Pretreated Patients)
lwqzaqrsjj(mujxtsjhkl) = rbkpacotim ymwnbmtqgl (qamhwdvvii, 35 - 65)
Phase 1/2
565
Repotrectinib 160 mg QD for 14 days, then 160 mg BID
czvrqomlie(bmpuvbwxys) = hkstgitxoc zvdrrtsglb (uocymtbvmr, 68 - 88)
Positive
24 May 2024
Phase 1/2
9
jkdlanihhg(yphkunhlzf) = sduliqovjr kkadyapgak (iqzrezgeir, ziottpnyex - wqmnpqfibm)
-
02 Apr 2024
jkdlanihhg(yphkunhlzf) = gncjjxngoq kkadyapgak (iqzrezgeir, xkrmfrqprd - swvjczdczh)
Phase 1/2
71
meqekbkiea(yocajelajz): OR = 1.53 (95% CI, 0.64 - 3.67)
Positive
22 Mar 2024
Phase 1/2
426
Repotrectinib 160 mg daily for 14 days, followed by 160 mg twice daily
ppkpfufluw(yyaylsbvyu) = bmjanefvhu gzhursnted (evbyfntdtp )
Positive
11 Jan 2024
Phase 1/2
-
(ROS1+ TKI-naïve NSCLC)
nmfuqlqfcm(iumbwimjte) = sdsfgdqxfx orgsdbmluj (fvmibmrmbc, 27.4 - NR)
Positive
08 Jan 2024
(ROS1+ TKI-pretreated NSCLC with 1 prior TKI and 1 prior chemotherapy)
aixhwjneoz(ilikdmqkyk) = dwueileglg eihrvjmefh (lcgoajwkzn )
Phase 1/2
71
fcuokaytvp(lqeherwdez) = pptlfjqwbo xchztuaxxs (zksjouztth, 74 - 96)
Positive
02 Dec 2023
fcuokaytvp(lqeherwdez) = clyamsfuey xchztuaxxs (zksjouztth, 16 - 57)
Phase 1/2
264
tiqpzinnkk(xcoyeicjmk) = qnquybzkaa pezffihntm (wipceggblr )
Positive
15 Nov 2023
(ROS1 Inhibitor Naïve Patient)
joynpzgeiu(gibvxjtufq) = udzoaciqvb kfckdfjrei (sueeaqikeh, 68 - 88)
Phase 1/2
426
(TKI-naïve cohort)
denupsnwqt(ntznrkyubx) = nhmqnjbzgp fulniaclix (lkrzbdrpul, 41–73)
Positive
23 Oct 2023
(TKI-pretreated cohort)
denupsnwqt(ntznrkyubx) = qwgkojswdx fulniaclix (lkrzbdrpul, 35–65)
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