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Enzastaurin - Aytu BioPharma/ Denovo Biopharma

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Drug Profile

Enzastaurin - Aytu BioPharma/ Denovo Biopharma

Alternative Names: AR-101 - Aytu BioPharma; DB 102; Enzastaurin hydrochloride; Kinenza; LY-317615

Latest Information Update: 03 May 2024

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At a glance

  • Originator Eli Lilly and Company
  • Developer Aytu BioPharma; Denovo Biopharma; Eli Lilly and Company
  • Class Antineoplastics; Indoles; Piperidines; Pyridines; Pyrrolidinones; Small molecules
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; Protein kinase C beta inhibitors; Protein-serine-threonine kinase inhibitors; Proto-oncogene protein c-akt inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Diffuse large B cell lymphoma; Glioblastoma; Ehlers-Danlos syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Diffuse large B cell lymphoma; Ehlers-Danlos syndrome; Glioblastoma
  • Preclinical Connective tissue disorders
  • Discontinued Brain cancer; Breast cancer; Cancer; Colorectal cancer; Follicular lymphoma; Lung cancer; Lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Ovarian cancer; Prostate cancer; Renal cancer; Solid tumours; Waldenstrom's macroglobulinaemia

Most Recent Events

  • 29 Feb 2024 Denovo Biopharma completes the phase-III ENGAGE trial in Glioblastoma (Adjuvant therapy, First-line therapy) in USA, Canada and China (NCT03776071)
  • 14 Oct 2022 Aytu Biopharma suspends the phase III PREVEnt trial in Ehlers Danlos Syndrome (Adjunctive treatment, Prevention, In adults) in France, Netherlands, Sweden (PO, Tablet), due to indefinite hold by the company (NCT05463679) (EudraCT2021-006574-23)
  • 12 Jul 2022 Denovo Biopharma completes the phase III ENGINE trial for Diffuse large B cell lymphoma (Combination therapy, First-line therapy) in China and USA (PO) (NCT03263026)

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