Exkivity

(Mobocertinib)

Phase 1Small molecule

Exkivity is a small molecule that works as a EGFR Exon 20 Inhibitor.[2] It is being investigated across 1 indication, with its most advanced program in Phase 1.[1]

Exkivity is one of 38 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerActive, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Preclinical

31 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Lenvima

Eisai

Preclinical

6 5

Imjudo

AstraZeneca

Preclinical

5 6

Vizimpro

Pfizer

Preclinical

4 7

Gilotrif

Boehringer Ingelheim

Preclinical

12 8

Ofev

Boehringer Ingelheim

Preclinical

7 9

Immunotherapy

Remeron

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT03807778

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

Active, not recruiting· Takeda logo

Takeda·Phase 1·NCT03807778·53 enrolled

An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations

Approved for marketing· Takeda logo

Takeda··NCT04535557

Hepatic Impairment (HI)1 trial

A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function

Completed· Takeda logo

Takeda·Phase 1·NCT04056468·24 enrolled

Kidney1 trial

A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys

Completed· Takeda logo

Takeda·Phase 1·NCT04056455·26 enrolled

Metabolism1 trial

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

Completed· Takeda logo

Takeda·Phase 1·NCT03811834·7 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 15, 2021

EXKIVITY

NDA NDA215310

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Mobocertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mobocertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mobocertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215310). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Exkivity. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: EGFR Exon 20 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Takeda

Patent Landscape[5]

Patent Cliff

May 13, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10227342May 13, 2035

9796712May 13, 2035

Exkivity

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Hepatic Impairment (HI)1 trial

Kidney1 trial

Metabolism1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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