Drugs / NAXTARUBICIN
NAXTARUBICIN
also known as
annamycin · liposomal annamycin · C-2632 · L-Annamycin · Naxtarubicina · Naxtarubicine
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00430443 | Feb 2007 → Jan 2009 | acute lymphoblastic leukemia, acute myeloid leukemia | Callisto Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT05319587 | Sep 2022 → Aug 2023 | acute myeloid leukemia | Moleculin Biotech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05518526 | Aug 2022 → Aug 2025 | soft tissue sarcoma | Maria Sklodowska-Curie National Research Institute of Oncology | Unknown | No outcome recorded |
| Phase 1/2 | NCT04887298 | Jun 2021 → Sep 2022 | soft tissue sarcoma | Moleculin Biotech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03388749 | Dec 2018 → Feb 2022 | acute myeloid leukemia | Moleculin Biotech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03315039 | Mar 2018 → Jan 2020 | acute myeloid leukemia | Moleculin Biotech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00271063 | Oct 2005 → Apr 2008 | acute lymphoblastic leukemia | Callisto Pharmaceuticals | Unknown | No outcome recorded |
| Phase 1/2 | NCT00012129 | Sep 1998 → May 2001 | breast cancer | NYU Langone Health | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 78
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Moleculin Biotech, Inc. | Results Moleculin’s MIRACLE R/R AML Trial Reports Positive Interim Data with 37% Blinded CRc in Venetoclax-Failed Patients moleculin.com ↗
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial (MB-108) of Annamycin in combination with cytarabine (AnnAraC) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). |
| 2026-07-06 | Moleculin Biotech, Inc. | Results Moleculin CEO, Walter Klemp, Highlights Positive Preliminary MIRACLE Trial Results in Virtual Investor “What This Means” Segment moleculin.com ↗
For the segment, Chairman and CEO Wally Klemp discusses the positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). |
| 2026-06-30 | Moleculin Biotech, Inc. | Results Moleculin Reports Positive Phase 2/3 MIRACLE Interim Results, With Annamycin Complete Remission Rates 3-fold Greater than Control moleculin.com ↗
Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML). |
| 2026-05-29 | Moleculin Biotech, Inc. | Results Moleculin Presents ASCO 2026 Data Demonstrating No Detectable Cardiotoxicity with Annamycin Despite Exposure Levels Far Exceeding Conventional Anthracycline Limits moleculin.com ↗
The analysis demonstrated no detectable cardiotoxicity despite cumulative exposure levels that substantially exceeded traditional lifetime anthracycline dose limitations. |
| 2026-05-21 | Moleculin Biotech, Inc. | Results Moleculin Highlights Abstract Accepted for Poster Presentation at the 2026 ASCO Annual Meeting Highlighting Cardiac Safety Data for Annamycin moleculin.com ↗
No statistically significant change in LVEF from baseline to final assessment (mean difference, -0.12%; 95% CI, -1.34 to 1.09; p = 0.84) |
| 2026-05-15 | Moleculin Biotech, Inc. | Results Moleculin Reports First Quarter 2026 Financial Results and Provides Clinical Update on Pivotal MIRACLE Trial moleculin.com ↗
The impressive preliminary blinded remission data trend we reported earlier this year continues with the 45 subject blinded data. |
| 2026-05-13 | Moleculin Biotech, Inc. | Results Moleculin Announces Imminent MIRACLE Trial Unblinding as Blinded Data Continue to Significantly Outperform Historical Benchmarks moleculin.com ↗
The Company also reported that preliminary blinded efficacy data for the 45 subjects continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. |
| 2026-05-12 | Moleculin Biotech, Inc. | Results Independent Cleveland Clinic Review Finds No Clinically Significant Cardiotoxicity with Moleculin’s Annamycin in R/R AML Patients Dosed Beyond Conventional Anthracycline Limits moleculin.com ↗
Importantly, the analysis demonstrated no clinically significant treatment-related cardiotoxicity across cumulative anthracycline-equivalent doses that exceeded conventional lifetime exposure limits associated with traditional anthracyclines. |
| 2026-04-23 | Moleculin Biotech, Inc. | Results Moleculin’s Annamycin Extends Survival by More Than 60% in Metastatic Pancreatic Cancer Preclinical Models – Data Presented at AACR 2026 moleculin.com ↗
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 highlighting the potential of its lead drug candidate, Annamycin, in pancreatic cancer. |
| 2026-03-19 | Moleculin Biotech, Inc. | Results Moleculin Reports Full Year 2025 Financial Results and Confirms Highly Anticipated 45-Patient Interim Data Unblinding in Pivotal MIRACLE Trial On Track for Mid-2026 moleculin.com ↗
Reported (n=30) MIRACLE Trial delivered 40% preliminary blinded CRc rate; |
| 2026-02-18 | Moleculin Biotech, Inc. | Results Moleculin MIRACLE Trial Delivers 40% Preliminary Blinded CRc Rate (n=30) moleculin.com ↗
Additionally, the Company reports a preliminary composite complete remission (CRc) rate of 40% in the MIRACLE trial’s first 30 subjects treated and with blinded, preliminary efficacy data. |
| 2026-01-13 | Moleculin Biotech, Inc. | Results Moleculin Reports Independent Assessment Confirms No Cardiotoxicity of Annamycin in 90 Subjects moleculin.com ↗
After review of certain data, the independent expert concluded that there was no evidence of cardiotoxicity. |
| 2025-08-27 | Moleculin Biotech, Inc. | Results Moleculin Issues New Positive AML Overall Survival Data: moleculin.com ↗
Median OS for Complete Remissions (CR): 15 months (n=8) with 4 subjects alive at study close |
| 2025-08-06 | Moleculin Biotech, Inc. | Results Moleculin Biotech, Inc. Unveils Promising Preclinical Data of Annamycin in Liver Cancer Treatment moleculin.com ↗
The preclinical studies confirmed that Annamycin exhibits distinct organotropic properties, leading to significantly higher concentrations in the liver, spleen, lungs, and pancreas when compared to doxorubicin (DOX). |
| 2025-07-09 | Moleculin Biotech, Inc. | Regulatory Moleculin Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia, Enrollment Update and Future Plans moleculin.com ↗
Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial |
| 2025-06-18 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML moleculin.com ↗ |
| 2025-06-05 | Moleculin Biotech, Inc. | Results Moleculin Releases On-Demand KOL Webcast to Discuss Data from its Phase 1B/2 Study of Annamycin for the Treatment of Soft Tissue Sarcoma (STS) Lung Metastases (MB-107) moleculin.com ↗ |
| 2025-06-04 | Moleculin Biotech, Inc. | Results Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107) moleculin.com ↗
Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin |
| 2025-05-12 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial moleculin.com ↗
EMA approval of the MIRACLE trial protocol is a huge milestone for us. |
| 2025-05-06 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin moleculin.com ↗
the International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved “naxtarubicin1” for the non-proprietary name of the Company’s next-generation anthracycline in development, Annamycin. |
| 2025-04-29 | Moleculin Biotech, Inc. | Results Moleculin Announces New Pre-Clinical Data for Annamycin Demonstrating Market Expansion Potential Including Treatment for Pancreatic Cancer moleculin.com ↗
The latest research continues to support our view that, in addition to hematological malignancies, solid cancers including sarcoma and pancreatic cancer also represent important expansion opportunities for Annamycin. |
| 2025-02-13 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Positive FDA Guidance for Acceleration of its Registration-Enabling MIRACLE Trial for R/R Acute Myeloid Leukemia (AML) moleculin.com ↗ |
| 2025-02-11 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives First Country Approval in Europe to Begin Recruiting for the MIRACLE Phase 3 R/R Acute Myeloid Leukemia (AML) Pivotal Trial moleculin.com ↗ |
| 2024-12-11 | Moleculin Biotech, Inc. | Results Moleculin Announces Online Publication of Preclinical Data Demonstrating Significant Activity of Annamycin in Venetoclax Resistant AML Model moleculin.com ↗
Study shows Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant acute myeloid leukemia (AML) cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro |
| 2024-11-18 | Moleculin Biotech, Inc. | Results New Findings Show Moleculin’s Annamycin Overcomes Resistance to Venetoclax in AML moleculin.com ↗
New preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or refractory to Venetoclax regimens; more than 4 times greater than published historical rates |
| 2024-09-23 | Moleculin Biotech, Inc. | Results Moleculin Announces Positive In Vivo Efficacy Data of Annamycin in Orthotopic and Experimental Lung Metastatic Models of Sarcoma moleculin.com ↗ |
| 2024-08-01 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces Plans for MIRACLE Phase 3 Pivotal Trial moleculin.com ↗ |
| 2024-06-14 | Moleculin Biotech, Inc. | Results Moleculin Announces Additional Positive Preliminary Interim Data from AML Clinical Trial moleculin.com ↗
Current median durability of response (mDOR) of CRc’s = 6 months and increasing (n=9) |
| 2024-05-09 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces U.S. Patent Issue Notification for Lipid-Based Delivery Technology for Annamycin moleculin.com ↗ |
| 2024-05-07 | Moleculin Biotech, Inc. | Results Moleculin Reports Higher AML Complete Remission (CR) Rates and Significant Durability with Additional Interim Subject Data moleculin.com ↗
Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13) |
| 2024-04-18 | Moleculin Biotech, Inc. | Regulatory European Medicines Agency (EMA) Grants Orphan Drug Designation for Moleculin’s Treatment of Acute Myeloid Leukemia (AML) moleculin.com ↗
today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Annamycin for the treatment of AML. |
| 2024-04-10 | Moleculin Biotech, Inc. | Results Moleculin Announces Presentation of Positive Data Demonstrating High Anti-Cancer Activity of Annamycin and Non-Cardiotoxic Properties moleculin.com ↗
today announced positive preclinical data regarding the Company’s next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting |
| 2024-03-25 | Moleculin Biotech, Inc. | Results Moleculin Announces Positive Interim Data in Annamycin MB-106 Phase 1B/2 AML Trial moleculin.com ↗
Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 60% (50% CR) in 2nd line AML subjects |
| 2024-01-24 | Moleculin Biotech, Inc. | Results Moleculin Announces 2023 Year-End Annamycin Clinical Trials Preliminary Data and 2024 Expectations for Multiple Data Readouts and Transition to Pivotal Phase 2B/3 moleculin.com ↗
100% of Annamycin subjects in multiple studies (N=62) continue to show no signs of cardiotoxicity during study as evidenced by an independent expert’s reports |
| 2023-12-11 | Moleculin Biotech, Inc. | Results Moleculin Presents Positive Interim Data from Phase 1B/2 Clinical Trial in AML at Meeting with KOL’s in Conjunction with ASH Annual Meeting moleculin.com ↗
CR rate of 44% in subjects treated with Annamycin (n=9) |
| 2023-11-13 | Moleculin Biotech, Inc. | Results Moleculin Announces Positive Interim Data in Annamycin Clinical Trials: MB-106 AML Trial Complete Response (CR) Rate of 38% and MB-107 STS Lung Mets Trial Median Phase 1B Extended Overall Survival of 11 Months moleculin.com ↗
100% of Annamycin subjects in multiple studies (N=66) continue to show no signs of cardiotoxicity during study |
| 2023-11-06 | Moleculin Biotech, Inc. | Results Moleculin Presents Positive Preliminary Efficacy Findings from Phase 1B/2 Clinical Trial Demonstrating 64% Stable Disease Rate Through Two Cycles of Annamycin for the Treatment of Soft Tissue Sarcomas (STS) Lung Metastases moleculin.com ↗ |
| 2023-09-18 | Moleculin Biotech, Inc. | Results Moleculin Announces New Positive Independent Report of No Cardiotoxicity in Annamycin moleculin.com ↗ |
| 2023-08-10 | Moleculin Biotech, Inc. | Results Moleculin Provides Update on Ongoing Clinical Trials and Outlines Expected Upcoming Milestones moleculin.com ↗
Reports preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of soft tissue sarcoma metastasized to the lungs with 73% (n=26) of the subjects exhibiting stable disease after two cycles of treatment |
| 2023-07-13 | Moleculin Biotech, Inc. | Results Moleculin Announces Publication of Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) moleculin.com ↗
today announced the publication of data from its completed MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory AML. |
| 2023-05-10 | Moleculin Biotech, Inc. | Results Moleculin Provides Update on Ongoing Clinical Trials and Outlines Expected Upcoming Milestones moleculin.com ↗
Preliminary results show a durable complete response at starting dose level in an elderly subject |
| 2023-05-02 | Moleculin Biotech, Inc. | Results Moleculin Successfully Completes First Cohort in Phase 1b/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML) moleculin.com ↗
Preliminary results demonstrate a durable complete response at starting dose level in elderly subject |
| 2023-04-18 | Moleculin Biotech, Inc. | Results Moleculin Announces Presentation of Positive Pharmacokinetics and Tissue-Organ Distribution Data Demonstrating High Antitumor Activity of Annamycin in Preclinical Cancer Models moleculin.com ↗ |
| 2023-03-09 | Moleculin Biotech, Inc. | Results Moleculin Announces Publication of Data Supporting Development of Non-Cardiotoxic Anthracycline for the Treatment of Cancer in Peer-Reviewed European Journal of Cancer moleculin.com ↗ |
| 2023-02-13 | Moleculin Biotech, Inc. | Results Moleculin Announces Final Topline Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) moleculin.com ↗
Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%. |
| 2022-12-15 | Moleculin Biotech, Inc. | Results Moleculin Reports 80% Overall Response Rate in Final Cohort of Phase 1 Single Agent Trial of Annamycin for the Treatment of Acute Myeloid Leukemia (AML) moleculin.com ↗ |
| 2022-07-28 | Moleculin Biotech, Inc. | Results Moleculin Concludes Phase 1b and Opens Recruitment in Phase 2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases moleculin.com ↗
Preliminary results from the study continue to document clinical activity for Annamycin in the treatment of STS. |
| 2022-05-05 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Allowance to Proceed with Phase 1/2 Study of Annamycin in Combination with Cytarabine for the Treatment of Acute Myeloid Leukemia (AML) moleculin.com ↗
today announced that it has received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) |
| 2022-04-11 | Moleculin Biotech, Inc. | Results /C O R R E C T I O N — Moleculin Biotech, Inc./ moleculin.com ↗
Annamycin exhibited robust antitumor activity in experimental colorectal cancer liver and lung metastasis models |
| 2022-04-08 | Moleculin Biotech, Inc. | Results Moleculin Announces Presentation of Positive Preclinical Annamycin Data at the AACR 2022 Annual Meeting moleculin.com ↗
Annamycin exhibited robust antitumor activity in experimental colorectal cancer liver and lung metastasis models |
| 2022-02-14 | Moleculin Biotech, Inc. | Results Moleculin Provides Annamycin AML Program Update and Outlines Next Steps to Advance Towards Late-Stage Development moleculin.com ↗
Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity (a common problem with currently prescribed anthracyclines). |
| 2022-01-18 | Moleculin Biotech, Inc. | Results Moleculin Announces Updated Preliminary Safety Data for Annamycin in Its Three Phase 1 Clinical Trials for Acute Myeloid Leukemia and Metastases of Soft Tissue Sarcoma moleculin.com ↗ |
| 2021-12-27 | Moleculin Biotech, Inc. | Results Moleculin Announces Preliminary Third Cohort Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases moleculin.com ↗ |
| 2021-10-18 | Moleculin Biotech, Inc. | Results Moleculin Announces Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases moleculin.com ↗ |
| 2021-07-13 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia moleculin.com ↗ |
| 2021-05-25 | Moleculin Biotech, Inc. | Regulatory Moleculin Commences Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Sarcoma Lung Metastases moleculin.com ↗ |
| 2021-03-30 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives FDA Approval of Fast Track Designation for Annamycin in the Treatment of Sarcoma Lung Metastases moleculin.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of soft tissue sarcoma (STS) lung metastases. |
| 2021-02-02 | Moleculin Biotech, Inc. | Results Moleculin Announces 100% Survival Achieved in Osteosarcoma Lung Metastases Animal Model moleculin.com ↗
While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals. |
| 2020-12-29 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces Annamycin Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas moleculin.com ↗
the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. |
| 2020-12-17 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases moleculin.com ↗
the US Food and Drug Administration (FDA) is allowing the company’s Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect. |
| 2020-11-19 | Moleculin Biotech, Inc. | Results Moleculin Announces New Data Demonstrating Synergistic Antitumor Activity of Annamycin Combination with Ara-C in AML moleculin.com ↗
The data is being presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology (“ASH”) under the title: “High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model.” |
| 2020-10-21 | Moleculin Biotech, Inc. | Results Moleculin Announces Independent Study Validates Annamycin’s Ability to Target Lung Localized Tumors moleculin.com ↗
Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, announced results from an independent laboratory validating internal animal studies showing the ability of Annamycin to target lung localized tumors. |
| 2020-09-09 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces Successful Completion of Pre-IND Meeting with the FDA moleculin.com ↗ |
| 2020-06-25 | Moleculin Biotech, Inc. | Results Moleculin Announces Preclinical Data Confirms Efficacy of Annamycin in Lung Metastases moleculin.com ↗
data demonstrating that uniquely high uptake and retention of Annamycin in the lungs results in consistently high in vivo activity against wide range of lung-localized tumors in mice. |
| 2020-06-04 | Moleculin Biotech, Inc. | Regulatory Moleculin Announces Submission to Expand Clinical Sites in European AML Trial moleculin.com ↗
today announced that it has submitted requests to Polish regulatory authorities for approval to open two additional clinical sites for its Phase 1/2 clinical study of Annamycin for the treatment of acute myeloid leukemia (“AML”). |
| 2020-04-28 | Moleculin Biotech, Inc. | Regulatory Moleculin Approved to Accelerate European Clinical Trial moleculin.com ↗ |
| 2020-04-02 | Moleculin Biotech, Inc. | Results Moleculin Announces Additional Positive Safety Data in EU AML Trial moleculin.com ↗
A total of 19 patients have been treated in the US and Europe, and all results continue to show Annamycin to be safe, and, especially, all have shown Annamycin to be free of cardiotoxicity. |
| 2020-02-20 | Moleculin Biotech, Inc. | Results Moleculin Announces Positive Independent Report of No Cardiotoxicity in Annamycin Phase 1 To Date moleculin.com ↗
After review of this data, the independent expert concluded that he “does not see evidence of cardio-toxicity.” |
| 2020-02-03 | Moleculin Biotech, Inc. | Results Moleculin Announces Successful Completion of US Phase 1 AML Trial of Annamycin moleculin.com ↗ |
| 2019-12-19 | Moleculin Biotech, Inc. | Results Moleculin Announces New Data Shows Reversal of Tumor Activity in Animal Models moleculin.com ↗
HOUSTON, Dec. 19, 2019 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced the presentation of a poster entitled, “Liposomal annamycin inhibition of lung localized breast cancer,” at the San Antonio Breast Cancer Symposium held December 14 – 29, 2019. |
| 2019-12-04 | Moleculin Biotech, Inc. | Results Moleculin Announces Additional Positive Interim Results from Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia moleculin.com ↗ |
| 2019-10-29 | Moleculin Biotech, Inc. | Results Moleculin Announces New Data Confirms Anti-tumor Efficacy of Annamycin in Both Human and Murine AML Models moleculin.com ↗ |
| 2019-07-18 | Moleculin Biotech, Inc. | Results Moleculin Announces Annamycin in Acute Myeloid Leukemia in Poland Advances to 3rd Cohort moleculin.com ↗ |
| 2019-05-07 | Moleculin Biotech, Inc. | Results Moleculin Announces Additional Positive Interim Results in First Cohort of Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia in Europe moleculin.com ↗
today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland. |
| 2019-04-18 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives FDA Approval of Fast Track Designation for Annamycin moleculin.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (“AML”). |
| 2019-04-17 | Moleculin Biotech, Inc. | Results Moleculin Announces Significant Discovery in Lung Cancer Models moleculin.com ↗
Annamycin is able to significantly improve survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models. |
| 2019-03-26 | Moleculin Biotech, Inc. | Results Moleculin Announces Positive Interim Results in First Cohort of Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia in the US and in Poland moleculin.com ↗
today announced positive interim safety and efficacy data from two ongoing open label, single arm Phase 1/2 studies of Annamycin. |
| 2018-06-20 | Moleculin Biotech, Inc. | Regulatory Moleculin Receives Approval for Leukemia Clinical Trial moleculin.com ↗ |
All press releases naming this drug 115 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 115 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NAXTARUBICIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068408 ↗ |
| Known as | annamycin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00012129 ↗ |
| Known as | C-2632 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068408 ↗ |
| Known as | L-Annamycin | “Liposomal Annamycin (L-Annamycin)” NCT04887298 ↗ |
| Known as | liposomal annamycin | “The project aims to conduct a Phase 1b/2 clinical trial using liposomal Annamycin (L-Annamycin) in subjects diagnosed with soft tissue sarcoma (STS) in the stage of...” NCT05518526 ↗3“Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer” NCT00012129 ↗ “Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML” NCT00430443 ↗ “Liposomal Annamycin (L-Annamycin)” NCT04887298 ↗ |
| Known as | Naxtarubicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068408 ↗ |
| Known as | Naxtarubicine | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068408 ↗ |
| Modality | Small molecule | — CHEMBL6068408 ↗ |
| Route | Intravenous | “Patients receive annamycin liposomal IV over 60 minutes on day 1.” NCT00012129 ↗ |