MedPath

Avatrombopag

Generic Name
Avatrombopag
Brand Names
Doptelet 60 Mg Daily Dose Carton, Doptelet
Drug Type
Small Molecule
Chemical Formula
C29H34Cl2N6O3S2
CAS Number
570406-98-3
Unique Ingredient Identifier
3H8GSZ4SQL

Overview

Avatrombopag (Doptelet), is an orally administered, small-molecule thrombopoietin receptor (c-Mpl) agonist which increases platelet number, but not platelet activation , . This decreases the need for blood transfusions . Patients with thrombocytopenia and chronic liver disease (leading to thrombocytopenia) often require platelet transfusions before surgical procedures to decrease the risk of bleeding . Thrombocytopenia (or decreased numbers of platelets) is a common complication in patients suffering from chronic liver disease, either as an immediate result of liver disease or a consequence of interferon-based antiviral therapy . Avatrombopag was approved by the FDA on May 21, 2018 for thrombocytopenia (low platelets) in adults with chronic liver disease who are scheduled to undergo a procedure . It is administered orally as avatrombopag maleate, its salt form . Doptelet (Avatrombopag) is the first orally administered treatment option for patients with chronic liver disease, allowing a large population of patients to avoid a platelet transfusion before a procedure by increasing platelet counts to the optimal level of greater or equal to 50,000 per microliter .

Background

Avatrombopag (Doptelet), is an orally administered, small-molecule thrombopoietin receptor (c-Mpl) agonist which increases platelet number, but not platelet activation , . This decreases the need for blood transfusions . Patients with thrombocytopenia and chronic liver disease (leading to thrombocytopenia) often require platelet transfusions before surgical procedures to decrease the risk of bleeding . Thrombocytopenia (or decreased numbers of platelets) is a common complication in patients suffering from chronic liver disease, either as an immediate result of liver disease or a consequence of interferon-based antiviral therapy . Avatrombopag was approved by the FDA on May 21, 2018 for thrombocytopenia (low platelets) in adults with chronic liver disease who are scheduled to undergo a procedure . It is administered orally as avatrombopag maleate, its salt form . Doptelet (Avatrombopag) is the first orally administered treatment option for patients with chronic liver disease, allowing a large population of patients to avoid a platelet transfusion before a procedure by increasing platelet counts to the optimal level of greater or equal to 50,000 per microliter .

Indication

Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure .

Associated Conditions

  • Thrombocytopenia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/04
Not Applicable
Not yet recruiting
Ostfold Hospital Trust
2024/02/28
Phase 2
Recruiting
2024/02/12
Phase 2
Not yet recruiting
2024/01/11
Phase 2
Recruiting
2023/08/22
Phase 2
Recruiting
2023/08/21
Phase 2
Recruiting
Second Affiliated Hospital of Guangzhou Medical University
2023/08/18
Phase 4
Completed
2023/04/21
N/A
Recruiting
Anhui Provincial Hospital
2023/03/16
Phase 2
Recruiting
Hanny Al-Samkari, MD
2023/02/09
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AkaRx, Inc.
71369-020
ORAL
20 mg in 1 1
6/7/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
6/20/2019

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Avatrombopag Maleate tablet
国药准字H20249300
化学药品
片剂
11/5/2024
Avatrombopag Maleate tablet
国药准字H20253106
化学药品
片剂
1/8/2025
Avatrombopag Maleate tablet
国药准字H20253117
化学药品
片剂
1/8/2025
Avatrombopag Maleate tablet
国药准字H20253526
化学药品
片剂
3/4/2025
Avatrombopag Maleate tablet
国药准字H20253548
化学药品
片剂
3/4/2025
Avatrombopag Maleate tablet
国药准字H20253325
化学药品
片剂
1/24/2025
Avatrombopag Maleate tablet
国药准字H20244130
化学药品
片剂
6/25/2024
Avatrombopag Maleate tablet
国药准字H20244142
化学药品
片剂
6/25/2024
Avatrombopag Maleate tablet
国药准字H20244403
化学药品
片剂
7/9/2024
Avatrombopag Maleate tablet
国药准字H20249585
化学药品
片剂
12/1/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
DOPTELET avatrombopag (as maleate) 20 mg film-coated tablets blister pack
375471
Medicine
A
1/16/2023
© Copyright 2025. All Rights Reserved by MedPath