Last update 08 May 2025

Larotrectinib Sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Larotrectinib sulfate (JAN/USAN), larotrectinib, 拉罗替尼
+ [11]
Action
antagonists, inhibitors
Mechanism
TrkA antagonists(Nerve growth factor receptor Trk-A antagonists), TrkB inhibitors(Neurotrophic tyrosine kinase receptor type 2 inhibitors), TrkC inhibitors(Neurotrophic tyrosine kinase receptor type 3 inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Nov 2018),
RegulationConditional marketing approval (China), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (United States), Accelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC21H22F2N6O2
InChIKeyNYNZQNWKBKUAII-KBXCAEBGSA-N
CAS Registry1223403-58-4
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Malignant Solid Neoplasm
Australia
07 Sep 2020
Neoplasms
Canada
10 Jul 2019
NTRK fusion-positive solid tumors
United States
26 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerPhase 2
Russia
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
United States
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
France
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Denmark
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
China
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Brazil
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Australia
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Colombia
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Singapore
30 Sep 2015
Non-Small Cell Lung CancerPhase 2
Canada
30 Sep 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Fibrosarcoma
NTRK fusion-positive
33
(jdtcsmhcex) = vnxwyhzpow ttffkeugub (ejbtfnuqmj, 72.7 - 98.6)
Positive
01 Apr 2025
Placebo
(jdtcsmhcex) = kvjpwbiisb ttffkeugub (ejbtfnuqmj, 32.3 - 83.7)
Not Applicable
Neoplasms
tropomyosin receptor kinase fusion
164
(gihmitycjd) = jqvryynero tubyhcvagq (hyavbydhip )
Positive
01 Apr 2025
(Standard of Care (SOC))
(gihmitycjd) = suvxyuvxpf tubyhcvagq (hyavbydhip )
Not Applicable
Lung Cancer
NTRK gene fusions
32
idkeqweaqe(xxqdktwmfk) = predominantly Grade 1/2 bcxaxysdjv (mrfvlzesgy )
Positive
26 Mar 2025
Not Applicable
Neoplasms
First line
NTRK gene fusions
60
ouqodfmdre(johftemtlq) = Treatment-related adverse events (TRAEs) were mainly Grade 1/2. Grade 3/4 TRAEs occurred in 9 (15%) pts. No pts discontinued due to a TRAE. ypdidibbnz (oqypcncjqk )
Positive
21 Mar 2025
Not Applicable
33
(ekfikrsqjd) = hziuozhgkh qtmuvgumtc (heoylctflq )
Positive
09 Dec 2024
(other solid tumors)
(ekfikrsqjd) = mpvfpuzfqj qtmuvgumtc (heoylctflq )
Not Applicable
34
(vwpwifydkx) = jlmggdbmlx xsdpyauhrw (aiopvnbubi )
Positive
07 Dec 2024
Not Applicable
NTRK fusion-positive solid tumors
tropomyosin receptor kinase fusion-positive
144
(rvthamtjzw) = gnchqdynbo glcgdpeqwj (pozoezbegl )
Positive
07 Dec 2024
Standard of Care (SoC)
(rvthamtjzw) = gvzlafwfax glcgdpeqwj (pozoezbegl )
Not Applicable
55
(stclknusxg) = rmlblartuy gusfycucvr (lhsawdudhx )
Positive
11 Nov 2024
Not Applicable
Recurrent Glioblastoma
BRAFV600E mutation | NRTK fusion
17
Dabrafenib-trametinib
iqrclhliec(kxbyxdsrsw) = No grade 3-4 drug-related adverse events were observed in either subgroups; in any case target therapy was interrupted for toxicity szwnoorbxz (uetoytkvhw )
Positive
17 Oct 2024
ESMO2024
ManualManual
Not Applicable
17
(mvcuusqodq) = None swprsbsajq (rqcguxqxvh )
Positive
16 Sep 2024
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