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SP-420

Phase 2

Beta Thalassemia Major Anemia | Small molecule | Oncology |Icon Plc|Last Updated: Sep 24, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

SP-420 · 1 trial · 2 indications

Phase 2 1
NCT05693909A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic SyndromesBeta Thalassemia Major Anemia
RECRUITING90 Analytics
PHASE2RECRUITING
A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
Beta Thalassemia Major Anemia
NCT0569390990
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Study Endpoints

Primary Endpoints

To establish dose-response relationship of SP-420 for 24 weeks in the treatment of subjects with transfusion-dependent β-thalassemia
24 weeks
To assess the safety and tolerability of ascending doses of SP-420 after 12 weeks treatment of subjects with transfusion-dependent low-risk myelodysplastic syndrome
12 weeks

Secondary Endpoints

To assess the efficacy of SP-420 in clearing iron from the liver after 24 weeks treatment of subjects with transfusion-dependent β-thalassemia
24 weeks
To assess the efficacy of SP-420 in clearing iron from the liver after 12 and 48 weeks treatment of subjects with transfusion-dependent β-thalassemia
12 and 48 weeks
To assess the efficacy of SP-420 on serum (s-) ferritin
up to 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1a-1bEXPERIMENTALSP-420 for 48 weeks
Cohort 2a-2bEXPERIMENTALSP-420 for 48 weeks
Cohort 3a-3bEXPERIMENTALSP-420 for 48 weeks
1c-1dEXPERIMENTALSP-420 for 48 weeks
2c-2dEXPERIMENTALSP-420 for 48 weeks
3c-3dEXPERIMENTALSP-420 for 48 weeks

Interventions

NameTypeDescription
SP-420DRUGCapsules for oral intake
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Thalassemia cohorts: Inclusion criteria: * Women and men aged 18 years or older * Transfusion-dependent β-thalassemia including HbE/β-thalassemia requiring iron chelation therapy (β-thalassemia with mutation and/or multiplication of α-globin is allowed) * On a stable dose of iron chelation for at ...

Countries:Denmark
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Frequently asked questions about SP-420

What is SP-420 used for?

SP-420 is an investigational small molecule being studied for the treatment of anemia in patients with transfusion-dependent beta thalassemia and low-risk myelodysplastic syndromes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing SP-420?

SP-420 is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 2 clinical trials for the treatment of anemia associated with beta thalassemia major and myelodysplastic syndromes.

What phase is SP-420 in?

SP-420 is currently in Phase 2 clinical development. It is being evaluated in an ongoing clinical trial for patients with transfusion-dependent beta thalassemia or low-risk myelodysplastic syndromes. The drug is investigational and has not yet been approved for commercial use.

What clinical trials is SP-420 in?

SP-420 is being studied in a single Phase 2 clinical trial registered as NCT05693909. This trial is recruiting 90 participants with transfusion-dependent beta thalassemia or low-risk myelodysplastic syndromes and is being conducted in Denmark. The trial is controlled but not double-blinded.

Is SP-420 the same as any other drug?

SP-420 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is a distinct small molecule being developed by Icon Plc for the treatment of anemia in certain blood disorders.