NCT05068388 is a Phase 2 clinical trial of Z-Endoxifen in Breast Density, sponsored by Atossa Therapeutics, Inc..

Who is sponsoring NCT05068388?

NCT05068388 is sponsored by Atossa Therapeutics, Inc..

What drugs are being tested in NCT05068388?

Interventions in NCT05068388: Z-Endoxifen, Placebo.

What condition does NCT05068388 study?

NCT05068388 studies Breast Density.

Is NCT05068388 still recruiting?

NCT05068388 is currently active, enrolled. Last updated 26 April 2024.

Last reviewed 2024-04-26 · How we verify

NCT05068388

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

Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Active, enrolled Phase 2 Last updated 26 April 2024

What this trial tests

Phase 2 trial testing Z-Endoxifen in Breast Density in 240 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 December 2021

Primary endpoint
28 August 2024

31 December 2025

Quick facts

Lead sponsor	Atossa Therapeutics, Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	21 December 2021
Primary completion	28 August 2024
Estimated completion	31 December 2025
Sites	1 location across Sweden

Drugs / interventions tested

Z-Endoxifen — full drug profile →
Placebo

Conditions studied

Breast Density — all drugs for Breast Density →

Sponsor

Atossa Therapeutics, Inc. — full company profile →

Who can join

Adults 40 to 55, female only, with Breast Density. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Endoxifen for mammographic density reduction-results from the KARISMA endoxifen trial.
Hall P, Hammarström M, Bergqvist J, Czene K, et al · · 2026 · PMID 42070780 · DOI 10.1093/jnci/djag087

Verify or expand the search:

Other trials of Z-Endoxifen

Trials testing the same drug.

NCT01273168 — Endoxifen in Adults With Hormone Receptor Positive Solid Tumors · Phase 1 · completed

Other Atossa Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04519788 — AT-301 Nasal Spray in Healthy Adults · Phase 1 · completed
NCT04616430 — Topical Endoxifen in Women · Phase 2 · 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 NCT05068388 (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 Atossa Therapeutics, Inc.
Last refreshed: 26 April 2024

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/NCT05068388.

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