Last update 23 Jul 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
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)
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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
Non-Small Cell Lung Cancer
Switzerland
06 Aug 2021
RET fusion-positive Thyroid Cancer
United States
01 Dec 2020
RET Mutation-Positive Medullary 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
Thyroid CancerNDA/BLA
European Union
-
metastatic non-small cell lung cancerPhase 3
China
27 Apr 2023
metastatic non-small cell lung cancerPhase 3
China
27 Apr 2023
AdenocarcinomaPhase 3
United States
-24 Jul 2020
AdenocarcinomaPhase 3
Japan
-24 Jul 2020
AdenocarcinomaPhase 3
Argentina
-24 Jul 2020
AdenocarcinomaPhase 3
Australia
-24 Jul 2020
AdenocarcinomaPhase 3
Belgium
-24 Jul 2020
AdenocarcinomaPhase 3
Brazil
-24 Jul 2020
AdenocarcinomaPhase 3
Costa Rica
-24 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
29
totuuiwhnc(vantnffagy) = imqmyomxcq udcxgbseyf (ohwrpgzgva )
Positive
30 May 2025
Phase 1/2
281
vmbtqpvxaj(jktnobuyje) = dcihwqtxke qmqnbwdqwp (dyycwgkguw, 64.3 - 75.8)
Positive
30 May 2025
Not Applicable
354
kibvypnine(ywtnmxbihu) = recurrent toxicity may occur in one-third of patients jhmxrokakv (zlpkqqwiyu )
Negative
30 May 2025
Not Applicable
15
dugdhtbqlz(wvrffqixsi) = 5.5% experienced cytomegalovirus pneumonia zovwooiwla (ojyestvigd )
-
28 Apr 2025
Phase 1/2
281
gjzaghjofx(agrxcahwht) = severe side effect in untreated patients wvsjcmouan (izrbteghmg )
Positive
01 Feb 2024
Phase 1/2
RET fusion-positive Thyroid Cancer
Rearranged During Transfection -Altered
145
Pralsetinib 400 mg once daily
ghrsmckwhg(fheyyycpyn) = qdcsctbzba wqsuftkqno (tzreulqzvg, 42.4 - 68.5)
Positive
01 Jan 2024
(treatment-naïve patients with RET-mutant MTC)
ghrsmckwhg(fheyyycpyn) = knstxaytqj wqsuftkqno (tzreulqzvg, 65.0 - 87.1)
Phase 1/2
68
Pralsetinib 400-mg once-daily oral
teskbzwzbp(ugzcfdatnr) = ravgetqgyn lpjfysyszf (rhdgwyxzox, 48.2 - 82.0)
Positive
06 Jun 2023
Phase 1/2
68
(previously treated with platinum-based chemotherapy)
invtpbifgq(wkttubudlo) = lpvdqhkkrp bgqjddpffj (srdpqfdtlx, 48 - 82)
Positive
03 Dec 2022
(treatment-naïve)
invtpbifgq(wkttubudlo) = caqlkxmbht bgqjddpffj (srdpqfdtlx, 65 - 94)
Pubmed
ManualManual
Not Applicable
59
(overall)
rxxjctklcs(ocaliggica) = lffeuqmfhz poehodqfhd (koxghkesrc, 4.7 - NA)
Positive
09 Nov 2022
(patients with measurable brain metastases)
qlqsihxipy(yvpvrixhuc) = hlzdsrvnoe afqompbkaf (dhokwhxzuk )
Phase 1/2
RET fusion-positive Non-Small Cell Lung Cancer
CCDC6-RET Fusion | KIF5B-RET Fusion | RET Fusion
233
zopypqqdku(yklruazetj) = ccrhafqmij mbxfkgxbav (wzmzuwwqfl, 60.0 - 74.8)
Positive
10 Sep 2022
zopypqqdku(yklruazetj) = tgcoyvevjb mbxfkgxbav (wzmzuwwqfl, 51.9 - 81.9)
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Approval

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Regulation

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