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Drug

Avatrombopag maleate

Approved · FDA / EMA
Late-stage development

Also known as Doptelet, Doptelet (40 mg daily-dose), Doptelet (60 mg daily-dose), avatrombopag (as maleate).

RxNorm2045727
8
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Indication expansion: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2025-07-24FDA

Label change: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2024-07-18FDA

Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure: A Prospective Non-randomized Controlled Trial

Clinical trial2023-06-30Primary completion · ClinicalTrials.gov

Label change: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2021-10-14FDA

Label change: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2020-08-20FDA

Indication expansion: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2019-06-26FDA

Approval: Doptelet (EMA)

Regulatory2019-06-20EMA

Label change: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2019-03-21FDA

Approval: AVATROMBOPAG MALEATE (NDA210238)

Regulatory2018-05-21FDA

A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal

Clinical trial2013-03-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Avatrombopag maleate
Aliases & brands
DopteletDoptelet (40 mg daily-dose)Doptelet (60 mg daily-dose)avatrombopag (as maleate)
RxNorm CUI
2045727
Regulatory jurisdictions
fdaema

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-05-21 → 2019-06-26)
Earliest approval
2018-05-21
Latest approval
2025-07-24
Authorities
FDA · EMA
Total events
8
fdaU.S. Food and Drug Administration· 7 events
2025-07-24Indication expansion
Indication expansion: AVATROMBOPAG MALEATE (NDA210238)
Evidence ↗
2024-07-18Label change
Label change: AVATROMBOPAG MALEATE (NDA210238)
Evidence ↗
2021-10-14Label change
Label change: AVATROMBOPAG MALEATE (NDA210238)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-06-20ApprovalMulti-authority
Approval: Doptelet (EMA)
Indication: Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is… Show full indication

Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

2 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
2
registered trials across all phases
LATEST COMPLETION 2013
1
Late-stage (III+)
1
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 2
Phase 11Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure: A Prospective Non-randomized Controlled Trial

Unknown statusPH IVChinese PLA General Hospitaln=4762023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.