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R906289 Monosodium

Phase 1

Low Risk Myelodysplastic Syndromes | Small molecule | Oncology |Rigel Pharmaceuticals, Inc.|Trials Updated: Aug 10, 2026

R906289 Monosodium development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2022

R906289 Monosodium target and mechanism

Molecular targetIRAK1/IRAK4
ModalitySmall molecule

Also known as R906289 Monosodium (R289 Na)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

R906289 Monosodium clinical trials

R906289 Monosodium · 1 trial · 1 indication

Phase 1 1
NCT05308264Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)Low Risk Myelodysplastic Syndromes
RECRUITING86 Analytics
PHASE1RECRUITING
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Low Risk Myelodysplastic SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
2 Year

* Incidence of adverse events (AEs) * Incidence of discontinuation or interruptions of R289 due to AEs * Incidence of dose limiting toxicities (DLTs)

Secondary Endpoints

Outcome Measure: Preliminary Efficacy
24 Weeks for Primary Efficacy; 8 Weeks for Characterized PK
Characterize pharmacokinetics (PK)
8 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ExperimentalEXPERIMENTALESCALATION PHASE: Dose Level 1: 250mg PO qd Dose Level 2: 500mg PO qd Dose Level 3: 750 mg PO qd Dose Level 4: 250 mg PO bid Dose Level 5: 500 mg PO AM/250 mg PO PM Dose Level 6: 500 mg PO bid EXPANSION PHASE (randomized 1:1): Dose Level 1: 250 mg PO qd Dose Level 2: 250 mg PO bid

Interventions

NameTypeDescription
R906289 Monosodium (R289 Na)DRUGDrug: R906289 Monosodium (R289 Na) R906289 Monosodium (250mg PO qd, 250mg PO bid, 500 mg PO qd, 500 mg PO bid, 750 mg PO qd, split dose - 500 mg PO AM/250 mg PO PM)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Patient must be ≥ 18 years of age at the time of signing the informed consent. * Must have definitive diagnosis of MDS with very low, low, or intermediate-1 risk (International Prognostic Scoring System (IPSS)-R ≤ 3.5) and ≤5% bone marrow myeloblasts. * Must be relapsed, refra...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT05308264lastUpdatePostDate: changed
LOWAug 11, 2026NCT05308264lastUpdatePostDate: changed
LOWAug 11, 2026NCT05308264lastUpdatePostDate: changed

Frequently asked questions about R906289 Monosodium

What is R906289 Monosodium used for?

R906289 Monosodium, also known as R289 Na, is an investigational small molecule being developed for the treatment of low risk myelodysplastic syndromes. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does R906289 Monosodium target?

R906289 Monosodium targets IRAK1 and IRAK4, which are kinases involved in inflammatory signaling pathways. By inhibiting these targets, the drug aims to address the underlying biology of low risk myelodysplastic syndromes.

Who makes R906289 Monosodium?

R906289 Monosodium is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is R906289 Monosodium in?

R906289 Monosodium is in Phase 1 clinical development. It is an investigational drug being studied in patients with low risk myelodysplastic syndromes, and it is not yet approved for commercial use.

What clinical trials is R906289 Monosodium in?

R906289 Monosodium is being evaluated in a Phase 1 clinical trial with the identifier NCT05308264. This open-label, uncontrolled study is recruiting approximately 86 participants with low risk myelodysplastic syndromes at sites in the United States.

Is R906289 Monosodium the same as R289 Na?

Yes, R906289 Monosodium is also known as R289 Na. Both names refer to the same investigational drug being developed by Rigel Pharmaceuticals for the treatment of low risk myelodysplastic syndromes.