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AAA817

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.

NOVARTIS AG NVS NVSEF · Prostate 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

    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
NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
Indication
Prostate 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 CompletedFirst trial start 27 Feb 20251 linked trial
  4. Phase 3 Current stageFirst trial start 27 Feb 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 AAA817. Editors add each one with its source.

Filed application

No filed application is on record for AAA817. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for AAA817.

Clinical trials

Trials linked to AAA817
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06855277ClinicalTrials.gov record for NCT06855277 (opens in a new tab)AcTFirstStudy Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPCPhase 3Recruiting940 (estimated)29 Sep 2028 (estimated) No
NCT06780670ClinicalTrials.gov record for NCT06780670 (opens in a new tab)PSMAcTIONOpen-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted TherapyPhase 2/3Recruiting443 (estimated)27 Jun 2028 (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 AAA817.

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.