NCT05377554 is a Phase 3 clinical trial of Bevonescein in Surgery, sponsored by Alume Biosciences, Inc..

Who is sponsoring NCT05377554?

NCT05377554 is sponsored by Alume Biosciences, Inc..

What drugs are being tested in NCT05377554?

Interventions in NCT05377554: Bevonescein, Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay, Intra-operative Visualization using White Light Reflectance (WLR).

Is NCT05377554 still recruiting?

NCT05377554 is currently completed. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05377554

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery

Completed Phase 3 Last updated 13 April 2026

What this trial tests

Phase 3 trial testing Bevonescein in Surgery in 154 participants. Completed in 24 November 2025.

Timeline

29 April 2022

Primary endpoint
27 October 2025

24 November 2025

Quick facts

Lead sponsor	Alume Biosciences, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	154
Start date	29 April 2022
Primary completion	27 October 2025
Estimated completion	24 November 2025
Sites	1 location across United States

Drugs / interventions tested

Bevonescein — full drug profile →
Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay
Intra-operative Visualization using White Light Reflectance (WLR)

Conditions studied

Surgery — all drugs for Surgery →

Sponsor

Alume Biosciences, Inc. — full company profile →

Who can join

16 and older, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines.
Xiao W, Jiang W, Chen Z, Huang Y, et al · · 2025 · cited 144× · PMID 40038239 · DOI 10.1038/s41392-024-02107-5
Improving precision surgery: A review of current intraoperative nerve tissue fluorescence imaging.
Wang LG, Gibbs SL. · · 2023 · cited 22× · PMID 37454623 · DOI 10.1016/j.cbpa.2023.102361
Infrared Fluorescence-guided Surgery for Tumor and Metastatic Lymph Node Detection in Head and Neck Cancer.
White HW, Naveed AB, Campbell BR, Lee YJ, et al · · 2024 · cited 6× · PMID 38940689 · DOI 10.1148/rycan.230178
Translation of Intraoperative Molecular Imaging for Clinical Use.
Rosenblum LT, Pant A, Yip C, Kohanbash G, et al · · 2026 · PMID 41927279 · DOI 10.2967/jnumed.124.268773

Verify or expand the search:

Other trials of Bevonescein

Trials testing the same drug.

NCT06227585 — Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery · Phase 2, PHASE3 · completed
NCT04420689 — Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Phase 1, PHASE2 · completed

Other recruiting trials for Surgery

Currently open trials in the same condition.

NCT07369921 — Pediatric Pilonidal Sinus Surgical Treatment · NA · recruiting
NCT07362303 — Neuralert Stroke Monitor Trial · NA · recruiting
NCT07404163 — Walkway Used in Postoperative Mobilization · NA · active not recruiting
NCT07218289 — Green Light for Post-Operative Wellness · NA · recruiting
NCT07342751 — The Effect of Listening to Music During Mobilization on Pain and Fear in Children Undergoing Abdominal Surgery · NA · active not recruiting

Other Alume Biosciences, Inc. trials

Trials by the same sponsor.

NCT06227585 — Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery · Phase 2, PHASE3 · completed
NCT04420689 — Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05377554 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alume Biosciences, Inc.
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05377554.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing