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 .

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
2025/08/21
Not Applicable
Recruiting
Al-Mustansiriyah University
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

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AkaRx, Inc.
71369-010
ORAL
10 mg in 1 1
8/13/2025
AkaRx, Inc.
71369-020
ORAL
20 mg in 1 1
8/13/2025

EMA Drug Approvals

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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.