Moleculin Biotech
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2006-01-01
- Employees
- 18
- Market Cap
- -
- Website
- http://www.moleculin.com
Clinical Trials
10
Trial Phases
2 Phases
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
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
- Conditions
- Acute Myeloid Leukaemia (AML)
- Interventions
- Drug: Placebo in combination with Cytarabine InjectionDrug: Liposomal Annamycin Injection in combination with Cytarabine InjectionDrug: 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)
- 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
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
- 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
- Conditions
- Sarcoma,Soft TissuePulmonary 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
Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL)
- 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.