COMPANY
Acrotech Biopharma
FDA-approved therapeutic company Clinical Phase 3
Timeline
- FDA FDA New drug/biologic (novel): ADQUEY (difamilast) — NDA219474, Feb 12, 2026. Applicant at approval: Acrotech Biopharma Inc. source ↗
- Trial start Phase 3: To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL source ↗
- Trial start Phase 1: Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Se source ↗
- Trial start Phase 3: This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) source ↗
- Trial start Phase 3: A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis source ↗
- Trial start Phase 1: PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients source ↗
- Trial start Phase 1: Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials source ↗
- Trial start Phase 1: Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes source ↗
- Trial start Phase 1: To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment. source ↗
- Trial start Phase 1: A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL) source ↗
- Trial start II: Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies source ↗
- Trial start I: Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer source ↗
- Trial start 1: Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL) source ↗
- Trial start 1: Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® source ↗
- Trial start 1: Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn source ↗
- Trial start Phase 2: Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation source ↗
- Trial start Phase 1/Phase 2: MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC source ↗
- Trial start Phase 1: To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer source ↗
- Trial start Phase 2: Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer source ↗
- Trial start Phase 1: Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma source ↗
- Trial start —: Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry source ↗
- Trial start Phase 2: PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation source ↗
- Trial start Phase 2: Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder source ↗
- Trial start Phase 1: Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma source ↗
- Trial start Phase 1/Phase 2: Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies source ↗
Upcoming milestones
- 2027-02 (ESTIMATED) · Phase 1 · Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepa · NCT07036133
- 2030-07 (ESTIMATED) · Phase 3 · To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL · NCT06072131
Clinical trials (lead sponsor) 28
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06072131 | To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL | Phase 3 | Recruiting | Oct 4, 2023 | 2030-07 (estimated) |
| NCT07036133 | Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment | Phase 1 | Recruiting | Dec 28, 2022 | 2027-02 (estimated) |
| NCT02680795 | Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes | Phase 1 | Completed | Apr 27, 2016 | Jul 21, 2020 (actual) |
| NCT05608343 | This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) | Phase 3 | Completed | Oct 1, 2022 | Oct 27, 2023 (actual) |
| NCT05571943 | A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis | Phase 3 | Completed | Sep 15, 2022 | Jul 31, 2024 (actual) |
| NCT04184869 | Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials | Phase 1 | Completed | Aug 5, 2019 | Dec 31, 2022 (actual) |
| NCT02594267 | A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL) | Phase 1 | Completed | Nov 10, 2015 | Apr 7, 2017 (actual) |
| NCT01660633 | Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation | Phase 2 | Completed | 2012-12 | 2014-02 (actual) |
| NCT04243434 | PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients | Phase 1 | Unknown status (ClinicalTrials.gov) | Aug 15, 2020 | Aug 15, 2020 (estimated) |
| NCT01820091 | Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® | 1 | Withdrawn | 2013-04 | 2015-04 (estimated) |
| NCT01789723 | Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn | 1 | Withdrawn | 2013-03 | 2015-03 (estimated) |
| NCT01222780 | To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer | Phase 1 | Completed | 2010-09 | 2014-12 (actual) |
| NCT01110733 | Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry | Not listed | Completed | 2010-02 | 2019-12 (actual) |
| NCT00481871 | Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies | Phase 1/Phase 2 | Completed | 2007-05 | 2011-05 (actual) |
| NCT01118624 | Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer | Phase 2 | Completed | 2010-03 | 2012-04 (actual) |
| NCT01310244 | MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC | Phase 1/Phase 2 | Completed | 2010-12 | 2015-08 (actual) |
| NCT01583777 | Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer | I | Completed | 2013-09 | 2015-04 (actual) |
| NCT01851551 | Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL | 1 | Completed | 2001-09 | 2004-04 (actual) |
| NCT01839097 | Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL) | 1 | Completed | 2013-05 | 2016-01 (actual) |
| NCT00554827 | Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma | Phase 1 | Completed | 2007-08 | 2012-01 (actual) |
| NCT00364923 | Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma | Phase 2 | Completed | 2006-08 | 2009-01 (actual) |
| NCT01134341 | Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma | Phase 1 | Completed | 2010-03 | 2015-08 (actual) |
| NCT00722553 | Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder | Phase 2 | Completed | 2008-07 | 2011-04 (actual) |
| NCT00925782 | PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation | Phase 2 | Completed | 2010-01 | 2011-06 (actual) |
| NCT00144963 | Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia | Phase 1/Phase 2 | Completed | 2002-07 | 2006-08 (actual) |
| NCT00145041 | Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction | Phase 1 | Completed | 2005-02 | 2007-09 (actual) |
| NCT02679131 | To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment. | Phase 1 | Terminated | 2016-03 | 2017-06 (actual) |
| NCT02106650 | Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies | II | Completed | 2014-07 | 2018-10 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): ADQUEY (difamilast) — NDA219474, Feb 12, 2026. Applicant at approval: Acrotech Biopharma Inc. source ↗
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