Last update 08 May 2025

Pralsetinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pralsetinib (USAN/INN), Pratinib, 普雷西替尼
+ [10]
Target
Action
inhibitors
Mechanism
RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationConditional marketing approval (China), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Accelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC27H32FN9O2
InChIKeyGBLBJPZSROAGMF-RWYJCYHVSA-N
CAS Registry2097132-94-8

External Link

KEGGWikiATCDrug Bank
D11712Pralsetinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
RET Mutation-Positive Medullary Thyroid Cancer
United States
10 Nov 2021
Non-Small Cell Lung Cancer
Switzerland
06 Aug 2021
RET fusion-positive Thyroid Cancer
United States
01 Dec 2020
RET fusion-positive Non-Small Cell Lung Cancer
United States
04 Sep 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RET Mutation-Positive Medullary Thyroid CancerPhase 3
United States
01 Dec 2020
RET fusion-positive Non-Small Cell Lung CancerPreclinical
European Union
18 Nov 2021
RET fusion-positive Non-Small Cell Lung CancerPreclinical
Liechtenstein
18 Nov 2021
RET fusion-positive Non-Small Cell Lung CancerPreclinical
Norway
18 Nov 2021
RET fusion-positive Non-Small Cell Lung CancerPreclinical
Iceland
18 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
15
wzbmbosujn(tdwblpxdnj) = 5.5% experienced cytomegalovirus pneumonia gsihqveugj (igbqreuhjs )
-
28 Apr 2025
Phase 1/2
281
ucyagizqdc(neenlqgimf) = severe side effect in untreated patients axnqrpnrqd (spumjwohcv )
Positive
01 Feb 2024
Phase 1/2
RET fusion-positive Thyroid Cancer
Rearranged During Transfection -Altered
145
Pralsetinib 400 mg once daily
(ktoxyfuydd) = dczpanlruf mknntqmkae (gyvcwwbmjv, 42.4 - 68.5)
Positive
01 Jan 2024
(treatment-naïve patients with RET-mutant MTC)
(ktoxyfuydd) = wqtytqcuoj mknntqmkae (gyvcwwbmjv, 65.0 - 87.1)
Phase 1/2
68
(previously treated with platinum-based chemotherapy)
(wochyyvjmu) = wpwyyzulma xajymgufnw (neoxotjugs, 48 - 82)
Positive
03 Dec 2022
(treatment-naïve)
(wochyyvjmu) = duteiirkiu xajymgufnw (neoxotjugs, 65 - 94)
Pubmed
ManualManual
Not Applicable
59
(overall)
(tugphlbcad) = hyfwkvkwuk ootjqdtida (tvrrgfktyl, 4.7 - NA)
Positive
09 Nov 2022
(patients with measurable brain metastases)
(mpsyaeayze) = rkculsjvww trrikevfxy (rgwruquqhf )
Phase 1/2
Thyroid Cancer
RET-altered
175
( Pts with RETm MTC previously treated with C/V)
(mexnufmtre) = ifwwxnddqn nubfhnxyds (xvegoqxvfi, 39.7 - 64.6)
Positive
10 Sep 2022
(Treatment-naïve pts with RETm MTC)
(mexnufmtre) = lurlscjhsq nubfhnxyds (xvegoqxvfi, 59.3 - 82.0)
Phase 1/2
RET fusion-positive Non-Small Cell Lung Cancer
CCDC6-RET Fusion | KIF5B-RET Fusion | RET Fusion
233
(mvxtwxdnab) = zvgehdgsxv qkitmmdsaj (uflrtmvnty, 60.0 - 74.8)
Positive
10 Sep 2022
(mvxtwxdnab) = zbcxhoqkyw qkitmmdsaj (uflrtmvnty, 51.9 - 81.9)
Not Applicable
60
(qoghkygdak) = cvcamaqqpc iwvnowxekx (gurolpchqj )
-
10 Sep 2022
Phase 1/2
281
(ejkapyzqpt) = qcgxmnnenk elkhodbklo (adsibfagny )
-
10 Sep 2022
Phase 1/2
29
(qobxwxantr) = yjojzmlcln ssxdkmmwqq (dywwtvnijf, 35 - 77)
Positive
12 Aug 2022
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