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    DRUG:

    Rezlidhia (olutasidenib)

    i
    Other names: FT-2102, FT 2102
    Company:
    Dr. Reddy’s, Kissei, Novo Nordisk, Orient Europharma, Rigel Pharmaceuticals
    Drug class:
    IDH1 inhibitor
    Related drugs:
    1m
    Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax (clinicaltrials.gov)
    P2, N=25, Recruiting, Timothy Pardee | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    Venclexta (venetoclax) • azacitidine • Rezlidhia (olutasidenib)
    2ms
    A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | Trial completion date: Aug 2029 --> Jun 2026 | Trial primary completion date: Aug 2027 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    azacitidine • Rezlidhia (olutasidenib)
    3ms
    A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=3, Recruiting, Kissei Pharmaceutical Co., Ltd.
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Rezlidhia (olutasidenib)
    3ms
    A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=45 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    azacitidine • Rezlidhia (olutasidenib)
    4ms
    Chemotherapy in dedifferentiated chondrosarcoma: from neoadjuvant to palliative treatment options. (PubMed, Crit Rev Oncol Hematol)
    CHT regimens usually mimic those used in osteosarcoma, including methotrexate-doxorubicin-cisplatin (MAP), doxorubicin-ifosfamide (AI), or doxorubicin-cisplatin (AP) - albeit with lower pathological response rates and substantial haematological toxicity. Emerging systemic treatment strategies were also described. Prospective data on the inhibition of mutant IDH1 indicate that olutasidenib (NCT03684811) can control the disease, but its activity in DCS is limited (median progression-free survival (PFS) of 1.5 months, 95% confidence interval (CI) 0.2-not reached (NR)).
    Review • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    cisplatin • doxorubicin hydrochloride • ifosfamide • methotrexate • Rezlidhia (olutasidenib)
    5ms
    Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies (clinicaltrials.gov)
    P4, N=16, Recruiting, Rigel Pharmaceuticals
    New P4 trial
    |
    Rezlidhia (olutasidenib)
    5ms
    Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Timothy Pardee
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    Venclexta (venetoclax) • azacitidine • Rezlidhia (olutasidenib)
    5ms
    Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Relapsed/Refractory Acute Myeloid Leukemia. (PubMed, Adv Ther)
    While not confirmatory, these findings may be clinically relevant in the context of this difficult-to-treat R/R IDH1m AML population.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    Tibsovo (ivosidenib) • Rezlidhia (olutasidenib)
    5ms
    The Care and Cure of the Leukemias in 2026. (PubMed, Am J Hematol)
    Currently, most leukemias are effectively treated with immunotherapies (highly effective monoclonal antibodies targeting CD19 [blinatumomab], or CD22 [inotuzumab ozogamicin]), BCR::ABL1 tyrosine kinase inhibitors (TKIs; e.g., dasatinib, ponatinib), Bruton TKIs (e.g., ibrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax), IDH1/2 inhibitors (ivosidenib, olutasidenib, and enasidenib), FLT3 inhibitors (e.g., midostaurin, quizartinib, and gilteritinib), menin inhibitors (revumenib, ziftomenib), and chimeric antigen receptor T-cell therapies. Herein, we provide a high-level overview of prominent clinical developments across all leukemias. In contemporary times, harnessing the benefits of novel targeted therapies and the evolving treatment landscape bolster the optimistic view that most, if not all, leukemias are curable.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
    |
    TP53 mutation • KMT2A mutation • MLL mutation
    |
    Venclexta (venetoclax) • dasatinib • Imbruvica (ibrutinib) • Iclusig (ponatinib) • Xospata (gilteritinib) • Blincyto (blinatumomab) • midostaurin • Calquence (acalabrutinib) • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Besponsa (inotuzumab ozogamicin) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib) • Rezlidhia (olutasidenib)
    5ms
    Differentiation Syndrome in Acute Myeloid Leukemia: Molecular Mechanisms, Clinical Spectrum, and Emerging Therapeutic Paradigms. (PubMed, Int J Mol Sci)
    While differentiation therapy revolutionized acute promyelocytic leukemia (APL) with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO), its extension into non-APL AML has been limited until recent targeted agents...IDH1/2 inhibitors (ivosidenib, enasidenib, olutasidenib) yield overall response rates (ORRs) of 30-94% in AML with DS in 10-19%. Menin inhibitors (revumenib, ziftomenib, enzomenib, bleximenib) achieve ORRs of 33-88% in KMT2A-rearranged or NPM1-mutated AML, with DS in 10-25% and QT prolongation as key toxicities. FLT3 inhibitors (gilteritinib, quizartinib) improve survival in FLT3-mutated AML with DS in 1-5%...Improved recognition of DS and rational combination approaches will be essential to maximize the therapeutic benefit. Future research should address mechanisms of resistance and biomarkers to achieve cures beyond APL.
    Review • Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    FLT3 mutation • NPM1 mutation
    |
    Xospata (gilteritinib) • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib) • Rezlidhia (olutasidenib) • arsenic trioxide • bleximenib (JNJ-6617) • enzomenib (DSP-5336)
    6ms
    Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    |
    Komzifti (ziftomenib) • Rezlidhia (olutasidenib)