What is Exkivity used for?

Exkivity is indicated for Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.

Exkivity is developed by Takeda.

What development phase is Exkivity in?

Exkivity is FDA-approved (marketed).

What is the generic name of Exkivity?

MOBOCERTINIB is the generic (nonproprietary) name of Exkivity.

Last reviewed 2026-04-20 · How we verify

Exkivity (MOBOCERTINIB)

Takeda · FDA-approved approved Small molecule Quality 28/100

At a glance

Generic name	MOBOCERTINIB
Sponsor	Takeda
Drug class	Kinase Inhibitor
Target	Receptor tyrosine-protein kinase erbB-4
Modality	Small molecule
Therapeutic area	Oncology
Phase	FDA-approved
First approval	2021

Approved indications

Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Common side effects

No common side effects on file.

Key clinical trials

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer (PHASE1,PHASE2)
Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE1)
A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer (PHASE1)
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations (PHASE3)
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations (PHASE1)
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants (PHASE1)
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys (PHASE1)
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function (PHASE1)

Patents

Patent	Expiry	Type

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results
FDA Orange Book	Patents + exclusivity

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Exkivity CI brief — competitive landscape report
Exkivity updates RSS · CI watch RSS
Takeda portfolio CI