相关临床试验
61
54 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
1996
进行中（未招募）
54
88.5%
已完成
7
11.5%
- Rigel Pharmaceuticals named Alison L. Hannah, M.D., as Executive Vice President and Chief Medical Officer, effective July 1, 2026, succeeding Lisa Rojkjaer, M.D. - Dr. Hannah brings decades of oncology drug development experience, including prior roles at CytomX Therapeutics and SUGEN, and has served on Rigel's Board of Directors since May 2021. - Her appointment comes as Rigel advances its lead pipeline asset R289, a dual IRAK1/4 inhibitor, through a Phase 1b study in relapsed or refractory lower-risk myelodysplastic syndrome. - The company expects to complete enrollment and select a recommended Phase 2 dose for R289 in the second half of 2026, with preliminary data anticipated by year-end.
- Rigel Pharmaceuticals published final Phase 1/2 ARROW study results in the Journal of Clinical Oncology, showing pralsetinib achieved a 70% overall response rate in patients with RET fusion-positive non-small cell lung cancer. - The study demonstrated median overall survival of 44.3 months in the overall population, with treatment-naïve patients achieving 50.1 months and prior-platinum patients reaching 39.7 months. - Pralsetinib showed intracranial activity with a 53% response rate in patients with measurable CNS metastases, supporting its potential value in advanced disease management. - The final data includes an additional 42 months of follow-up, reinforcing the drug's manageable safety profile with no new safety signals observed.
- Rigel Pharmaceuticals reported updated Phase 1b data for R289, an oral IRAK1/4 dual inhibitor, showing 33% of transfusion-dependent lower-risk MDS patients achieved red blood cell transfusion independence at doses ≥500 mg daily. - The study enrolled 33 heavily pre-treated patients with median age 75 and median 3 prior therapies, demonstrating R289's tolerability with manageable side effects including diarrhea, constipation, and fatigue. - Peak hemoglobin increases of 2.9 to 6.1 g/dL occurred in patients achieving transfusion independence, with median duration of 22.9 weeks and some patients maintaining independence for over 24 weeks. - The company plans to complete dose expansion with up to 40 patients and select the recommended Phase 2 dose in the second half of 2026.
- Rigel Pharmaceuticals has enrolled the first patient in the dose expansion phase of its Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, for transfusion-dependent relapsed or refractory lower-risk myelodysplastic syndrome. - The dose expansion phase will randomize up to 40 patients to receive 500 mg R289 either once or twice daily to determine the recommended Phase 2 dose for future clinical development. - R289 has received FDA Orphan Drug designation for myelodysplastic syndromes and Fast Track designation for previously-treated transfusion-dependent lower-risk MDS, addressing a persistent unmet medical need. - The company completed dose escalation enrollment in July 2025 and expects to share updated study data later this year, with an additional exploratory cohort planned once the recommended Phase 2 dose is established.
- Rigel Pharmaceuticals' lead product Tavalisse generated $68.5 million in sales during the first half of 2025, representing a 44% year-over-year increase. - The company's second FDA-approved drug Rezlidhia showed strong momentum with 31% year-over-year growth to $13.1 million in sales. - Rigel raised its 2025 revenue guidance to $270-$280 million from the previous expectation of $200-$210 million due to strong commercial performance. - The company is advancing R289, a dual IRAK1/IRAK4 inhibitor, in Phase Ib trials for myelodysplastic syndrome with dose expansion planned for the second half of 2025.
- Over 10 companies are developing 12+ RIPK1 inhibitor therapies targeting inflammatory and neurodegenerative diseases, with key players including Sanofi, Rigel Pharmaceuticals, and GenFleet Therapeutics advancing promising candidates. - Sanofi discontinued its Phase 2 trial of oditrasertib in multiple sclerosis after failing to meet primary endpoints, highlighting the challenges in targeting neurodegeneration with RIPK1 inhibition. - Leading pipeline candidates include SAR443122 for cutaneous lupus and ulcerative colitis, GFH312 as China's first clinical-stage RIPK1 inhibitor, and R552 developed through Rigel's collaboration with Eli Lilly. - RIPK1 inhibitors represent a novel therapeutic approach by blocking inflammation and cell death pathways, offering potential treatments for autoimmune disorders, neurodegenerative conditions, and inflammatory diseases.
- Final data from the Phase 1/2 ARROW study demonstrates GAVRETO's durable efficacy in RET fusion-positive NSCLC, with a 70.3% overall response rate and median overall survival of 44.3 months. - GAVRETO shows promising anti-tumor activity in various RET fusion-positive solid tumors beyond lung cancer, including a 100% response rate in pancreatic cancer patients. - REZLIDHIA data supports its potential clinical benefit when used in earlier treatment lines for relapsed/refractory AML patients and as maintenance therapy, with particularly strong outcomes in patients with fewer prior therapies.
- DelveInsight's 2025 assessment reveals a robust sickle cell disease pipeline with 55+ companies developing 60+ therapeutic candidates across various clinical development stages. - Recent clinical milestones include Rigel Pharmaceuticals enrolling the first patient in a Phase I trial of fostamatinib and Beam Therapeutics presenting updated BEACON trial data for BEAM-101. - The pipeline encompasses diverse therapeutic approaches including gene therapies, small molecules, and monoclonal antibodies, with treatments administered through multiple routes from oral to intravenous. - Key marketed therapies include Vertex Pharmaceuticals' CASGEVY, a CRISPR/Cas9 gene-edited cell therapy, and Emmaus Medical's ENDARI, an oral L-glutamine treatment for reducing acute complications.
• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.
- Rigel Pharmaceuticals achieved significant revenue growth in 2024, with TAVALISSE sales increasing 12% to $104.8 million and REZLIDHIA sales growing 118% to $23.0 million. - The company secured key regulatory approvals for TAVALISSE in South Korea and Mexico, while establishing a new partnership with Dr. Reddy's Laboratories for REZLIDHIA commercialization across multiple territories. - Rigel's R289 program for lower-risk MDS received FDA Fast Track designation, with promising Phase 1b data presented at ASH 2024 showing good tolerability and preliminary efficacy.
