Last update 27 Feb 2026

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
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (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 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
Non-small cell lung cancer stage IIIBPhase 2
Italy
-23 May 2019
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
South Korea
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
354
bqxpyqvngl(psqcxudglb) = xmcowrpaxz wukymrpsry (tqebpmuscg )
Not Met
Negative
29 Jan 2025
Pemetrexed plus cisplatin or carboplatin
bqxpyqvngl(psqcxudglb) = izgpvbjhrt wukymrpsry (tqebpmuscg )
Not Met
Not Applicable
-
wrauzdkjxk(ltgsrrneob) = ucslzjhwge lvjelweasa (stxipfryni )
-
07 Sep 2024
wrauzdkjxk(ltgsrrneob) = pscbxhebvw lvjelweasa (stxipfryni )
Phase 1
Solid tumor
HER2 mutations
28
xleybxbhvq(uqyrrlgbcn) = grade ≥ 3 AE occurred in 72.7% of pts; the common events (>5%) being thrombocytopenia (50.0%), diarrhea (13.6%), and anorexia (13.6%) afckdpdrud (vgjbwbzfji )
Positive
24 May 2024
Phase 1
EGFR exon 20 insertion mutations
-
latwkmjjbv(mbeqgtnfnz) = all adverse events were Grade 1 in severity obvetageip (grcuhmiqbr )
-
24 May 2024
[14C]-Mobocertinib 50 µg
Phase 1
26
(Part A: Midazolam Alone)
jmhxiwvjfj(ilecvxrrcl) = atvxbibzes uhjnsvimss (nplgfjujgl, 60.2)
-
12 Apr 2024
(Part A: Midazolam + Mobocertinib)
jmhxiwvjfj(ilecvxrrcl) = lbrjgbitna uhjnsvimss (nplgfjujgl, 60.7)
Phase 1
26
(Severe Renal Impairment: Mobocertinib 80 mg)
mldvsyvnxz(lgcjfkdttw) = thvzmklpsc zkheszbzuv (fpzzbbudvz, 326)
-
08 Jan 2024
(Normal Renal Function: Mobocertinib 80 mg)
mldvsyvnxz(lgcjfkdttw) = pkizdzpeua zkheszbzuv (fpzzbbudvz, 69.8)
Phase 3
EGFR exon 20 positive Neoplasms
First line
EGFR ex20ins+
354
qwslzxymku(pufsnzqfbz) = bxiyijicsc kqjxzdwmsj (qysnbixnoi )
Negative
02 Dec 2023
qwslzxymku(pufsnzqfbz) = owbexmdguk kqjxzdwmsj (qysnbixnoi )
Phase 1/2
Non-Small Cell Lung Cancer
EGFR ex20ins-positive
57
ohlgtgcsdy(equecbaacp) = shgjrwalkb zdjefxjxgw (zbhlctbjiz )
-
02 Dec 2023
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
EGFR exon 20 insertion mutations
105
wzudowxbhk(hqtiubdsso) = 51 patients (48.6%) reported diarrhea (all grades) related to mobocertinib (treatment discontinuation due to diarrhea: 4 patients [7.8%]) ijgoykxyfb (eebgpiskuh )
Positive
02 Dec 2023
Phase 1
24
(Moderate HI (Child-Pugh B): Mobocertinib 40 mg)
llwqljvcub(jrcioaiqre) = hmntnlrnef vrjiqmrwby (weenxvthfp, 58.2)
-
03 Nov 2023
(Severe HI (Child-Pugh C): Mobocertinib 40 mg)
llwqljvcub(jrcioaiqre) = rpdowhqxfs vrjiqmrwby (weenxvthfp, 31.7)
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