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Doptelet
Published
Product name
Doptelet
Active ingredient
Avatrombopag maleate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Doptelet (avatrombopag maleate) was approved for the following therapeutic use:
Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
How this medicine works
Avatrombopag is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Doptelet was considered favourable for the therapeutic use approved.
Sponsor