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R906289 Monosodium

Phase 1

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

Target and mechanism

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

Clinical trial landscape

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 in Low Risk Myelodysplastic Syndromes?

R906289 Monosodium is an investigational small molecule being studied for the treatment of Low Risk Myelodysplastic Syndromes. It is currently in Phase 1 clinical development, with an active trial recruiting patients in the United States. The drug has not been approved by the FDA and remains under clinical investigation.

Who makes R906289 Monosodium?

R906289 Monosodium is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RIGL. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with Low Risk Myelodysplastic Syndromes.

What phase is R906289 Monosodium in?

R906289 Monosodium is in Phase 1 clinical development. It is being evaluated in an ongoing, uncontrolled trial for Low Risk Myelodysplastic Syndromes. The drug is investigational and has not received FDA approval. The Phase 1 study is currently recruiting participants in the United States.

What clinical trials is R906289 Monosodium in?

R906289 Monosodium is being studied in clinical trial NCT05308264, titled 'Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)'. This Phase 1 trial is recruiting 86 participants aged 18 years and older in the United States. The study is uncontrolled and not blinded.

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 Low Risk Myelodysplastic Syndromes. The drug is currently in Phase 1 clinical trials under the identifier NCT05308264.