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Uproleselan

Phase 3

Relapsed/Refractory AML | Small molecule | Oncology |Apollomics Inc.|Trials Updated: Jun 27, 2025

Uproleselan development status

Highest phase Phase 3 (NCT05054543)
Phase scored for APLMPhase 1
Registered trials 14 across 6 sponsors since Jun 2014

Uproleselan target and mechanism

Molecular targetSELE
Target classAntagonist
ModalitySmall molecule

Also known as GMI-1271

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Uproleselan clinical trials

Uproleselan · 1 trial · 1 indication

Phase 1 1
NCT04839341Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML PatientsRelapsed/Refractory AML
COMPLETED12 Analytics
PHASE1COMPLETED
Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients
Relapsed/Refractory AMLUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak plasma concentration (Tmax)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

Peak plasma concentration (Cmax)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

The Incidence of Adverse Events
Up to 10 months

Number of participants with an AE.

The tolerance of participants with relapsed/refractory AML.
Up to 10 months

Number of participants could tolerate the Uproleselan combined with chemotherapy.

Secondary Endpoints

OS
Up to 3 years
Remission rate (rate of CR, CR/CRi and CR/CRh)
Up to 60 days
CTCAE grade 3 and 4 oral mucositis
Up to 254 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A Phase I, open-labeled multicenter studyEXPERIMENTALUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC)

Interventions

NameTypeDescription
UproleselanDRUGA rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. ≥18 years and ≤60 years in age 2. AML (including secondary AML) diagnosed as per WHO standards (2008). 3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied ...

Countries:China
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Frequently asked questions about Uproleselan

What is uproleselan used for?

Uproleselan is being developed for the treatment of relapsed or refractory acute myeloid leukemia (AML). It is an investigational small molecule studied in combination with chemotherapy in adult patients with relapsed or refractory AML. It is not yet approved for any indication.

What does uproleselan target?

Uproleselan targets SELE, also known as E-selectin, and acts as an antagonist. By blocking E-selectin, uproleselan is designed to interfere with interactions between leukemia cells and the bone marrow microenvironment. This mechanism is intended to make AML cells more responsive to chemotherapy.

Who is developing uproleselan?

Uproleselan is being developed by Apollomics Inc., which trades under the ticker APLM. The company is advancing the asset in oncology, specifically for relapsed or refractory AML.

What phase is uproleselan in?

Uproleselan is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The completed Phase 1 trial evaluated the drug in Chinese patients with relapsed or refractory AML.

What clinical trials is uproleselan in?

Uproleselan has been studied in one completed clinical trial, NCT04839341, titled a study to evaluate pharmacokinetics and safety with uproleselan combined with chemotherapy to treat Chinese relapsed or refractory AML patients. The Phase 1 trial enrolled 12 adults in China and was uncontrolled, non-randomized, and not double-blinded.