MedPath

Moleculin Biotech

Moleculin Biotech logo
🇺🇸United States
Ownership
Public
Established
2006-01-01
Employees
18
Market Cap
-
Website
http://www.moleculin.com

Clinical Trials

10

Active:4
Completed:5

Trial Phases

2 Phases

Phase 1:8
Phase 2:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
8 (80.0%)
phase_1_2
1 (10.0%)
Phase 2
1 (10.0%)

L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

Phase 2
Recruiting
Conditions
Acute Myeloid Leukaemia (AML)
Interventions
Drug: Placebo in combination with Cytarabine Injection
Drug: Liposomal Annamycin Injection in combination with Cytarabine Injection
Drug: Liposomal Annamycin for Injection in combination with Cytarabine Injection.
First Posted Date
2025-01-23
Last Posted Date
2025-07-18
Lead Sponsor
Moleculin Biotech, Inc.
Target Recruit Count
334
Registration Number
NCT06788756
Locations
🇺🇸

Bioresearch Partners, Miami, Florida, United States

🇬🇪

GEORGIA: LLC ARENSIA Exploratory Medicine, Tbilisi, Georgia

🇺🇦

ARENSIA Exploratory Medicine, LLC, Kyiv, Ukraine

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

Phase 1
Active, not recruiting
Conditions
Leukemia, Myeloid, Acute
Interventions
First Posted Date
2022-04-08
Last Posted Date
2024-12-20
Lead Sponsor
Moleculin Biotech, Inc.
Target Recruit Count
63
Registration Number
NCT05319587
Locations
🇮🇹

Istituto Scientifico Romagolo per lo studio dei umori "Dino Amadori" (IRST) - IRCCS, Meldola, FC, Italy

🇮🇹

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

🇮🇹

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy

and more 6 locations

Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
Drug: Placebo
First Posted Date
2022-01-19
Last Posted Date
2023-02-27
Lead Sponsor
Moleculin Biotech, Inc.
Target Recruit Count
48
Registration Number
NCT05195723
Locations
🇬🇧

Medicines Evaluation Unit, Manchester, United Kingdom

Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases

Phase 1
Completed
Conditions
Sarcoma,Soft Tissue
Pulmonary Metastasis
Interventions
First Posted Date
2021-05-14
Last Posted Date
2024-10-24
Lead Sponsor
Moleculin Biotech, Inc.
Target Recruit Count
36
Registration Number
NCT04887298
Locations
🇺🇸

Sarcoma Oncology Center, Santa Monica, California, United States

🇺🇸

Washington University, Saint Louis, Missouri, United States

🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 2 locations

Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL)

Phase 1
Completed
Conditions
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Interventions
First Posted Date
2021-01-11
Last Posted Date
2021-01-11
Lead Sponsor
Moleculin Biotech, Inc.
Target Recruit Count
5
Registration Number
NCT04702503
Locations
🇵🇱

Medical University of Gdansk, Gdansk, Poland

  • Prev
  • 1
  • 2
  • Next

News

Moleculin Appoints Roche Veteran Adriano Treve as Strategic Advisor Ahead of Phase 3 AML Trial Data

Moleculin Biotech has appointed Adriano Treve, a 40-year Roche veteran, as Strategic Advisor for partnerships as the company approaches key milestones in its Phase 3 MIRACLE trial.

Moleculin Biotech Raises $5.9 Million to Advance Annamycin Through Phase 3 AML Trial

Moleculin Biotech completed a $5.9 million public offering to fund advancement of its lead drug candidate Annamycin through clinical development.

FDA Approves Expanded Pediatric Trial for Moleculin's Annamycin in Acute Myeloid Leukemia

FDA has approved Moleculin's pediatric study plan for Annamycin in combination with cytarabine as second-line therapy for children with relapsed/refractory acute myeloid leukemia.

Annamycin Shows 59% Clinical Benefit Rate in Soft Tissue Sarcoma Lung Metastases Phase 2 Trial

Annamycin demonstrated a 59.4% clinical benefit rate in patients with soft tissue sarcoma lung metastases, comprising 18 patients with stable disease and 1 with partial response in the phase 1b/2 MB-107 trial.

EMA Approves Moleculin's Phase IIb/III Trial Application for AML Treatment

Moleculin Biotech has received European Medicines Agency approval for its Phase IIb/III clinical trial investigating a novel treatment for acute myeloid leukemia.

WHO Approves "Naxtarubicin" as International Generic Name for Moleculin's Cancer Drug Annamycin

Moleculin Biotech's next-generation anthracycline Annamycin receives WHO approval for the international non-proprietary name "naxtarubicin," marking a significant milestone in its development and potential commercialization.

Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

FDA Guidance Enables Moleculin to Streamline Phase 3 Trial for Novel AML Treatment AnnAraC

Moleculin Biotech receives FDA feedback allowing a 10% reduction in Phase 3 trial size for AnnAraC, their combination therapy targeting refractory/relapsed Acute Myeloid Leukemia.

Moleculin Biotech's Annamycin Shows Promise in Overcoming Treatment Resistance in AML

Moleculin Biotech's Annamycin demonstrates the ability to overcome resistance to Venetoclax in acute myeloid leukemia (AML) based on preclinical and clinical data.

Moleculin Biotech Accelerates Data Readout for Annamycin AML Trial

Moleculin Biotech amended its Phase 3 MIRACLE trial protocol for Annamycin, aiming for accelerated approval in relapsed/refractory AML.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.