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Doptelet

(Avatrombopag)

ApprovedSmall molecule

Avatrombopag is a medication that helps increase platelet production in the blood. It is used to treat low platelet counts in patients with liver disease who need a medical or dental procedure, and in patients with a chronic immune disorder causing low platelets who haven't responded to other treatments.[2] Doptelet is currently approved and in use across 11 indications[4].[1]

Doptelet is one of 265 small molecule programs targeting Aplastic Anemia. It is currently in Approved.

11

Indications

47

Total Trials

9

Active Trials

264

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Aplastic AnemiaApproved

Thrombocytopenic PurpuraActive, not recruiting

ThrombocytopeniaActive, not recruiting

HemorrhageActive, not recruiting

Blood Platelet DiseaseApproved

Chronic HepatitisActive, not recruiting

Liver DiseaseApproved

Severe Aplastic AnemiaApproved

Hepatocellular CarcinomaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Aplastic AnemiaApproved

Approved

Thrombocytopenic PurpuraPhase 3

Active, not recruiting

ThrombocytopeniaApproved

Active, not recruiting

HemorrhageApproved

Active, not recruiting

Blood Platelet DiseaseApproved

Approved

Chronic HepatitisPhase 2

Active, not recruiting

Liver DiseaseApproved

Approved

Severe Aplastic AnemiaApproved

Approved

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Immune ThrombocytopeniaPhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

797 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Doptelet

Coreg

Akero Therapeutics

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Opdivo

Bristol-Myers Squibb

PD-1 Inhibitor

Johnson & Johnson

Statin

Bristol-Myers Squibb

QL1706

Qilu Pharmaceutical Co., Ltd.

Rivoceranib

EElevar Therapeutics

Anti-PD-1 Monoclonal Antibody

IiTeos Therapeutics

PD-1

SSichuan Baili Pharmaceutical Co., Ltd.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Malignancies

NCT05772546

Q3 2027

Post-ApprovalRecruiting

Pilot Study

NCT07133659

Q4 2028

Phase 2/3Not yet recruiting

Immune Thrombocytopenia

NCT07278908

Q4 2029

Phase 3Not yet recruiting

Study completion

NCT07051915

Clinical

Trials by Indication[1]

Thrombocytopenia18 trials

Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

Unknown status·TTongji Hospital·Phase 4·NCT04906083·150 enrolled

Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant

Withdrawn·AAyman Saad·Phase 2·NCT04312789

Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

Completed· Eisai logo

Eisai·Phase 2·NCT00914927·130 enrolled

Show 15 more trials

Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04896528·30 enrolled

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Completed·SSobi, Inc.·Phase 3·NCT03471078·122 enrolled

Avatrombopag for Chemotherapy-induced Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05218226·50 enrolled

Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure

Completed· Eisai logo

Eisai·Phase 3·NCT01976104·204 enrolled

Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure

Completed· Eisai logo

Eisai·Phase 3·NCT01972529·231 enrolled

Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure

Terminated·SSobi, Inc.·Phase 3·NCT03326843·4 enrolled

Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Completed·SSobi, Inc.·Phase 3·NCT05369208·19 enrolled

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Recruiting·PPeking University People's Hospital·Phase 2/3·NCT06202625·142 enrolled

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia

Completed· Eisai logo

Eisai·Phase 2·NCT02227693·39 enrolled

Study of Avatrombopag for Temozolomide-induced Thrombocytopenia in Glioma (APATIT-G)

Withdrawn·UUniversity of Rochester·Phase 1·NCT04931849

Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors

Completed·—·N/A·NCT04609891·74 enrolled

Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

Terminated·SSobi, Inc.··NCT03554759·50 enrolled

Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma

Unknown status·SSun Yat-sen University·Phase 2·NCT04797182·46 enrolled

Avatrombopag for Thrombocytopenia in People With Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04437953

Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC

Unknown status·SSecond Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT06001567·30 enrolled

Immune Thrombocytopenia6 trials

Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2/3·NCT07278908·248 enrolled

Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06281327·60 enrolled

Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT04993885·52 enrolled

Show 3 more trials

Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)

Unknown status·SShandong University··NCT04949009·400 enrolled

Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)

Completed· Eisai logo

Eisai·Phase 3·NCT01438840·49 enrolled

Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

Completed·SSobi, Inc.·Phase 3·NCT04516967·75 enrolled

Efficacy and Safety5 trials

Efficacy and Safety of Avatrombopag vs. Avatrombopag Combined With rhTPO in the Treatment of SAA

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06254287·60 enrolled

Efficacy and Safety of CsA+AVA in the Treatment of NSAA in the Elderly

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT06004752·30 enrolled

Efficacy and Safety of Avatrombopag Combined With IST for the Treatment of HAAA and SAA With Abnormal Liver Function

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT05571332·39 enrolled

Show 2 more trials

Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 4·NCT05382013·60 enrolled

Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT05433922·80 enrolled

Safety and Efficacy2 trials

The Safety and Efficacy Study of Avatrombopag Switch in TPO-RA Refractory AA

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT05518331·39 enrolled

Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months

Withdrawn·SSobi, Inc.·Phase 3·NCT05046327

Thrombocytopenic Purpura2 trials

Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Completed· Eisai logo

Eisai·Phase 2·NCT00441090·64 enrolled

A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Terminated· Eisai logo

Eisai·Phase 3·NCT01433978·24 enrolled

13 more indications

Treatment2 trials

A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT02039076·48 enrolled

CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly

Completed·PPeking Union Medical College Hospital·Phase 4·NCT05996393·86 enrolled

Interaction1 trial

Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT02809768·48 enrolled

Chronic Hepatitis1 trial

Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501

Completed· Eisai logo

Eisai·Phase 2·NCT01355289·65 enrolled

Effectiveness1 trial

An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP

Completed·SSwedish Orphan Biovitrum··NCT04943042·199 enrolled

Malignancies1 trial

Avatrombopag vs. Placebo for CIT in GI Malignancies

Active, not recruiting·—·Phase 2·NCT05772546·60 enrolled

Pilot Study1 trial

Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study

Recruiting·—·Phase 4·NCT07133659·25 enrolled

Satisfaction1 trial

Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim

Completed·SSobi, Inc.·Phase 4·NCT04638829·60 enrolled

Age1 trial

Avatrombopag Usage in NSAA

Unknown status·PPeking Union Medical College Hospital·Phase 2/3·NCT04728789·40 enrolled

Bone Marrow Failure1 trial

Avatrombopag for Platelet Recovery Post-UCBT in Patients With Bone Marrow Failure Disease

Recruiting·—··NCT05823376·40 enrolled

HSCT1 trial

Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05143892·20 enrolled

Hepatocellular Carcinoma1 trial

Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma

Unknown status·SShanghai Zhongshan Hospital··NCT05087459·141 enrolled

First-line Treatment1 trial

Avatrombopag Combined With IST as First-line Treatment for SAA

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05720234·53 enrolled

Unspecified1 trial

The Holistic Study

Not yet recruiting·OOstfold Hospital Trust·Phase 3·NCT07051915·220 enrolled

Regulatory

FDA Approval Timeline[5]

May 21, 2018

DOPTELET

NDA NDA210238

Jul 24, 2025

DOPTELET SPRINKLE

NDA NDA219696

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Avatrombopag. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Doptelet drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Avatrombopag compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Avatrombopag. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219696). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Doptelet. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Akarx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombopoietin Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAkarx

Patent Landscape[6]

Patent Cliff

Jul 28, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7638536Jul 28, 2027

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