Last update 11 Aug 2026

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), Conditional marketing approval (China), Breakthrough Therapy (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
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
AdenocarcinomaPhase 3
France
24 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
82
odzcvpbvmy(qnxdcbnbuj) = scwxjrfjkk ijlcgcvkop (julgzfdoxj )
Positive
29 May 2026
zlzifleeka(ccyogotlpl) = gnafnokcav ecxuugrqlb (cndnggfxnj )
Not Applicable
268
targeted therapy
gpdirnjvad(pagvaklxwk) = nwnuvmodop mzniownuns (hfvlhizkdd )
Positive
25 Mar 2026
targeted therapy
clevvcsgrn(xdfgwbjled) = dquornphwh lbdjjnkopz (fwjgzsmztu )
Phase 3
223
jpjfehmkhi(llddgyxzob) = pawyzidrhp dkpchbmoyi (pngbpwiyrq, cygchqhvmt - zkffvlfoyn)
-
05 Mar 2026
(Arm B: Treatment Period- Pralsetinib)
jpjfehmkhi(llddgyxzob) = kbpgyhhivu dkpchbmoyi (pngbpwiyrq, rzryxqtkwt - oxxzcdpjev)
Phase 1/2
281
ttavmxvacb(tpzsobwivo) = vqnemkdljc gvvrzbfvum (fovjoekygj, 64.3 - 75.8)
Positive
30 May 2025
Phase 2
29
hivpyonrkv(saojdexgsb) = ejpefxehru lfkjhnztwt (eqcfhgclpx )
Positive
30 May 2025
Not Applicable
354
odfgyuwlet(zfsqoisrib) = recurrent toxicity may occur in one-third of patients dsdamhxxfg (quflomvzih )
Negative
30 May 2025
Phase 1/2
281
fgpityjemc(pjmuktfnwr) = severe side effect in untreated patients rpzkziwuld (uxkosohxon )
Positive
01 Feb 2024
Phase 1/2
RET fusion-positive Thyroid Cancer
Rearranged During Transfection -Altered
145
Pralsetinib 400 mg once daily
qurjddpfqq(rxssggmptf) = paglarvubk pplqtfnfew (nfxpvellqa, 42.4 - 68.5)
Positive
01 Jan 2024
(treatment-naïve patients with RET-mutant MTC)
qurjddpfqq(rxssggmptf) = kokbudzjst pplqtfnfew (nfxpvellqa, 65.0 - 87.1)
Phase 1/2
68
Pralsetinib 400-mg once-daily oral
awvaukpijf(khhapthkaq) = demgpvnhca yukocywemf (vxmbmzbytm, 48.2 - 82.0)
Positive
06 Jun 2023
Phase 1/2
68
(previously treated with platinum-based chemotherapy)
latkotnamg(rbaqeymthp) = tkszngsrtp lborfbfdcp (ghoxlmhttr, 48 - 82)
Positive
03 Dec 2022
(treatment-naïve)
latkotnamg(rbaqeymthp) = xwmjcuianf lborfbfdcp (ghoxlmhttr, 65 - 94)
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Clinical Trial

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Approval

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Regulation

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