TAK-788

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

TAKEDA PHARMACEUTICAL CO LTD TAK TKPHF · Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indication
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 10 Jan 20201 linked trial
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for TAK-788. Editors add each one with its source.

Filed application

No filed application is on record for TAK-788. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for TAK-788.

Clinical trials

Trials linked to TAK-788
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04129502ClinicalTrials.gov record for NCT04129502 (opens in a new tab)TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion MutationsPhase 3Completed354 (actual)22 Sep 2026 (actual) No

Publications listing NCT04129502 (1), newest first

  1. First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025 May

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as TAK-788.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.