NCT05319587 is a Phase 1, PHASE2 clinical trial of Liposomal Annamycin in Leukemia, Myeloid, Acute, sponsored by Moleculin Biotech, Inc..

Who is sponsoring NCT05319587?

NCT05319587 is sponsored by Moleculin Biotech, Inc..

What drugs are being tested in NCT05319587?

Interventions in NCT05319587: Liposomal Annamycin, Cytarabine.

What condition does NCT05319587 study?

NCT05319587 studies Leukemia, Myeloid, Acute.

Is NCT05319587 still recruiting?

NCT05319587 is currently completed. Last updated 30 September 2025.

Last reviewed 2025-09-30 · How we verify

NCT05319587

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

Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)

Completed Phase 1, PHASE2 Last updated 30 September 2025

What this trial tests

Phase 1, PHASE2 trial testing Liposomal Annamycin in Leukemia, Myeloid, Acute in 22 participants. Completed in 10 August 2023.

Timeline

29 September 2022

Primary endpoint
2 August 2023

10 August 2023

Quick facts

Lead sponsor	Moleculin Biotech, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	29 September 2022
Primary completion	2 August 2023
Estimated completion	10 August 2023
Sites	9 locations across Italy, Poland

Drugs / interventions tested

Liposomal Annamycin — full drug profile →
Cytarabine — full drug profile →

Conditions studied

Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →

Sponsor

Moleculin Biotech, Inc. — full company profile →

Who can join

18 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1/2, multicenter, open-label, dose-escalation study that will determine the MTD and RP2D of L-Annamycin in combination with cytarabine for the treatment of subjects with AML.

Publications & conference data

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

Development and application of nanomaterials, nanotechnology and nanomedicine for treating hematological malignancies.
Li J, Wang Q, Han Y, Jiang L, et al · · 2023 · cited 24× · PMID 37353849 · DOI 10.1186/s13045-023-01460-2
Navigating the Clinical Landscape of Liposomal Therapeutics in Cancer Treatment.
Kozak A, Lavrih E, Mikhaylov G, Turk B, et al · · 2025 · cited 12× · PMID 40006643 · DOI 10.3390/pharmaceutics17020276
EHA2024 Hybrid Congress
· 2024

Verify or expand the search:

Other trials of Liposomal Annamycin

Trials testing the same drug.

NCT03388749 — Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) · Phase 1, PHASE2 · completed
NCT03315039 — Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) · Phase 1, PHASE2 · completed

Other recruiting trials for Leukemia, Myeloid, Acute

Currently open trials in the same condition.

NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting

Other Moleculin Biotech, Inc. trials

Trials by the same sponsor.

NCT05195723 — Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers · Phase 1 · completed
NCT04887298 — Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases · Phase 1, PHASE2 · completed
NCT04702503 — Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL) · Phase 1 · completed
NCT03388749 — Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) · Phase 1, PHASE2 · completed
NCT03315039 — Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) · 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 NCT05319587 (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 Moleculin Biotech, Inc.
Last refreshed: 30 September 2025

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/NCT05319587.

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