AU-011

Phase 2Small molecule

AAura Biosciences

AU-011 is one of 21 small molecule programs targeting Non Muscle Invasive Bladder Cancer. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non Muscle Invasive Bladder CancerActive, not recruiting

MetastasesRecruiting

Non Muscle Invasive Bladder CancerPhase 1

Active, not recruiting

MetastasesPhase 2

Recruiting

Competition

Competitive Landscape

17 competitors in Non Muscle Invasive Bladder Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

3 2

Taxotere

AAvyxa

Phase 3

3 3

Bacillus Calmette-Guerin

AstraZeneca

Phase 3

2 4

Disitamab Vedotin

Pfizer

Phase 2

1 5

Cretostimogene Grenadenorepvec

CCG Oncology, Inc.

Phase 3

3 6

Nadofaragene Firadenovec

Ferring

Phase 3

2 7

Trodelvy

Gilead

Preclinical

1 8

TARA-002

PProtara Therapeutics

Phase 2

1 9

Gemcitabin

GGerman Cancer Research Center

Phase 2

1 10

Theracys® BCG

FFudan University

Phase 2

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT05483868

Q4 2027

Phase 2Recruiting

Metastases

NCT06643884

Clinical

Trials by Indication[1]

Melanoma2 trials

Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

Terminated·AAura Biosciences··NCT05266430·2 enrolled

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Completed·AAura Biosciences·Phase 2·NCT04417530·22 enrolled

Metastases1 trial

Suprachoroidal Administration in Subjects With Metastases to the Choroid

Recruiting·AAura Biosciences·Phase 2·NCT06643884·24 enrolled

Non Muscle Invasive Bladder Cancer1 trial

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer

Active, not recruiting·AAura Biosciences·Phase 1·NCT05483868·55 enrolled

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for AU-011. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AU-011 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AU-011. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Aura Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: AAura Biosciences

AU-011

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Trials by Indication[1]

Melanoma2 trials

Metastases1 trial

Non Muscle Invasive Bladder Cancer1 trial

References

Drug Info

Quick Facts

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