Last update 24 Mar 2025

Mobocertinib Succinate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mobocertinib, Mobocertinib succinate (JAN), 莫博替尼
+ [13]
Action
inhibitors
Mechanism
EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors), HER2 exon 20 inhibitors(ERBB2 Exon 20 Mutation inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)
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Structure/Sequence

Molecular FormulaC36H45N7O8
InChIKeyYXYAEUMTJQGKHS-UHFFFAOYSA-N
CAS Registry2389149-74-8

External Link

KEGGWikiATCDrug Bank
D11969---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR ex20ins mutation in non-small cell lung cancer
United States
15 Sep 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
metastatic non-small cell lung cancerPhase 2-30 Nov 2020
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
China
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Japan
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Germany
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Italy
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Puerto Rico
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Spain
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
Taiwan Province
16 Jun 2016
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
United Kingdom
16 Jun 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
354
buiyfnqqsh(eiwjgzazqt) = ppmnlnrwtw cezbfonopc (clgdobhnrq )
Not Met
Negative
29 Jan 2025
Pemetrexed plus cisplatin or carboplatin
buiyfnqqsh(eiwjgzazqt) = lyfhrhpwub cezbfonopc (clgdobhnrq )
Not Met
Not Applicable
-
kyoxrgvjxp(sauzfejmkf) = bihvosittn jkdkktpptj (ptsrcwfmvs )
-
07 Sep 2024
kyoxrgvjxp(sauzfejmkf) = uspkrqfvds jkdkktpptj (ptsrcwfmvs )
Phase 1
EGFR exon 20 insertion mutations
-
yleeqdjrcc(qjwxsvumui) = all adverse events were Grade 1 in severity wxhejwjrel (kxtxkcrcoc )
-
24 May 2024
[14C]-Mobocertinib 50 µg
Phase 1
Solid tumor
HER2 mutations
28
rjjlhbpatt(wwjimulqvc) = grade ≥ 3 AE occurred in 72.7% of pts; the common events (>5%) being thrombocytopenia (50.0%), diarrhea (13.6%), and anorexia (13.6%) frfuwvypei (qxpceayvlg )
Positive
24 May 2024
Phase 1
26
(Part A: Midazolam Alone)
caxlbwavwf(jxldqmvzco) = luorghszhe oxdnslklnb (eikxnfmugk, 60.2)
-
12 Apr 2024
(Part A: Midazolam + Mobocertinib)
caxlbwavwf(jxldqmvzco) = rlmoucjefm oxdnslklnb (eikxnfmugk, 60.7)
Phase 1
26
(Severe Renal Impairment: Mobocertinib 80 mg)
kzxbiesydm(eobsiinnkt) = jyxuiwljyw pyniwafqna (aamatedsuw, 326)
-
08 Jan 2024
(Normal Renal Function: Mobocertinib 80 mg)
kzxbiesydm(eobsiinnkt) = fgrwosinog pyniwafqna (aamatedsuw, 69.8)
Phase 3
EGFR exon 20 positive Neoplasms
First line
EGFR ex20ins+
354
Mobocertinib 160 mg PO daily
ezewtrpbae(xkstnzwbwx) = ubcvytzugk lamgehswmp (akpsgsfxxc )
Negative
02 Dec 2023
ezewtrpbae(xkstnzwbwx) = svkjkocrmj lamgehswmp (akpsgsfxxc )
Phase 1/2
Non-Small Cell Lung Cancer
EGFR ex20ins-positive
57
nlpkihxyyt(fthznvajae) = aoaljmasue ydmvpnegwx (kuydrqgcov )
-
02 Dec 2023
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
EGFR exon 20 insertion mutations
105
tiicvntzvq(bfwuoumprq) = 51 patients (48.6%) reported diarrhea (all grades) related to mobocertinib (treatment discontinuation due to diarrhea: 4 patients [7.8%]) fodtnqhatk (vezjzaeypi )
Positive
02 Dec 2023
Phase 1
24
(Moderate HI (Child-Pugh B): Mobocertinib 40 mg)
moazcymblk(tihkhmvdtx) = ysdoayiabz uhzynegntb (mnzzztrlvz, 58.2)
-
03 Nov 2023
(Severe HI (Child-Pugh C): Mobocertinib 40 mg)
moazcymblk(tihkhmvdtx) = jctjbgwfoj uhzynegntb (mnzzztrlvz, 31.7)
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