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AK112

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.

Summit Therapeutics Inc. SMMT · Non-Squamous Non-small Cell Lung Cancer

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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

Sponsor
Summit Therapeutics Inc. SMMT Source: Company record for Summit Therapeutics Inc. (opens in a new tab)
Indication
Non-Squamous Non-small Cell Lung Cancer 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 4 May 20231 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 AK112. Editors add each one with its source.

Filed application

No filed application is on record for AK112. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for AK112.

Clinical trials

Trials linked to AK112
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06396065ClinicalTrials.gov record for NCT06396065 (opens in a new tab)Phase III Study of AK112 for NSCLC PatientsPhase 3Active, not recruiting420 (actual)12 Apr 2025 (actual) No

Publications listing NCT06396065 (1), newest first

  1. Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial.

    The Lancet. Oncology · 2026 Sep

    PubMed 42636833 (opens in a new tab)DOI 10.1016/S1470-2045(26)00282-2 (opens in a new tab)

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 AK112.

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

Related news

Sources

Record updated .

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