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EIK1001

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.

Eikon Therapeutics, Inc. EIKN · Advanced Melanoma; Non Small Cell Lung Cancer (Squamous or Non Squamous); Stage 4 NSCLC

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 2/3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Eikon Therapeutics, Inc. EIKN Source: Company record for Eikon Therapeutics, Inc. (opens in a new tab)
Indications
Advanced Melanoma; Non Small Cell Lung Cancer (Squamous or Non Squamous); Stage 4 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 Current stageFirst trial start 22 May 20252 linked trials
  4. Phase 3 Current stageFirst trial start 22 May 20252 linked trials
  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 EIK1001. Editors add each one with its source.

Filed application

No filed application is on record for EIK1001. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for EIK1001.

Clinical trials

Trials linked to EIK1001
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07365319ClinicalTrials.gov record for NCT07365319 (opens in a new tab)TeLuRide-008A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.Phase 2/3Recruiting750 (estimated)31 Dec 2035 (estimated) No
NCT06697301ClinicalTrials.gov record for NCT06697301 (opens in a new tab)Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.Phase 2/3Recruiting740 (estimated)Dec 2035 (estimated) No

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 EIK1001.

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.