Drugs / roginolisib
roginolisib
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT07203391 | Feb 2026 → Dec 2027 expected | uveal melanoma | St Vincent's Hospital, Sydney | Recruiting | No outcome recorded |
| Phase 1 | NCT04328844 | Feb 2020 → Dec 2023 overdue | myelofibrosis, non-Hodgkin lymphoma, non-small cell lung carcinoma, uveal melanoma | iOnctura | Active not recruiting | Met primary |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07847957 | Jan → Apr 2027 expected | B-cell chronic lymphocytic leukemia | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06887803 | Nov 2025 → Mar 2028 expected | myelofibrosis | iOnctura | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07018752 | Aug 2025 → Apr 2028 expected | peripheral T-cell lymphoma, not otherwise specified | The Lymphoma Academic Research Organisation | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06879717 | Apr 2025 → Jan 2027 expected | non-small cell lung carcinoma | iOnctura | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06644183 | Mar 2025 → Oct 2028 expected | B-cell chronic lymphocytic leukemia | Jennifer R. Brown, MD, PhD | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06717126 | Feb 2025 → Dec 2027 expected | uveal melanoma | iOnctura | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | iOnctura | Results A promising new chapter for PI3Kδ inhibition: Nature Communications publications reveal novel mechanism behind iOnctura’s roginolisib ionctura.com ↗
Second publication outlines first-in-human (FiH) study results, demonstrating roginolisib’s favorable tolerability profile and encouraging clinical findings in patients with cancer, including metastatic uveal melanoma (mUM) |
| 2024-12-11 | iOnctura | Results iOnctura reaches new clinical milestones in uveal melanoma ionctura.com ↗
Patients with uveal melanoma showed a doubling of overall survival compared to historical controls |
| 2023-12-08 | iOnctura | Results Updated clinical safety and efficacy data for iOnctura’s roginolisib presented at ESMO immuno-oncology congress 2023 ionctura.com ↗
Mass cytometry data showed treatment with roginolisib led to an increase in activated anti-cancer CD8+ T-cells and natural killer (NK) cells , increased interferon signalling and a decrease in cancer- promoting Regulatory T-cells. |
| 2023-10-31 | iOnctura | Regulatory iOnctura announces FDA clearance of IND application for roginolisib, a first-in-class allosteric modulator of PI3Kδ ionctura.com ↗
iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, today announces that the US Food and Drug Administration (FDA) has granted permission to proceed with clinical investigations of roginolisib in the United States of America. |
| 2023-03-28 | iOnctura | Regulatory iOnctura awarded UK’s MHRA innovation passport for entry into innovative licensing and access pathway (ILAP) ionctura.com ↗
today announces that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, for the treatment of metastatic uveal melanoma |
| 2023-03-16 | iOnctura | Results iOnctura announces publication of pioneering research describing the unique biological features of roginolisib ionctura.com ↗
The research published in Cancer Research Communications reinforces the conclusion that roginolisib inhibits regulatory T cell proliferation while having limited anti-proliferative effects on conventional CD4+ T cells and no effect on CD8+ T cells. |
| 2023-01-05 | iOnctura | Results iOnctura provides development update on first-in-class semi-allosteric PI3Kδ inhibitor program ionctura.com ↗
Updated clinical data demonstrates a prolonged and sustained favorable safety profile for roginolisib (IOA-244) |
| 2022-05-27 | iOnctura | Results iOnctura to present at ASCO IOA-244 showing highly promising impact on overall survival for patients with metastatic and refractory uveal melanoma ionctura.com ↗
We observed, in patients who progressed on prior therapies, that IOA -244 stabilized their disease and halted the progression after we had exhausted all prior therapies , |
| 2022-05-17 | iOnctura | Results iOnctura to present at ASCO encouraging Phase Ib refractory uveal melanoma data for first semi-allosteric PI3Kδ inhibitor, IOA-244 ionctura.com ↗
The data presented at ASCO will show that IOA-244 has potentially best-in-class tolerability and impressive overall survival in refractory uveal melanoma patients. |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Roginolisib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06644183 ↗ |
| Known as | IOA-244 | “A Phase 1b and 2 Study of Roginolisib (IOA-244) Combined With Obinutuzumab Followed by Venetoclax in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) After...” NCT07847957 ↗2“A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 \[roginolisib hemi-fumarate\]) in combination with dostarlimab with or without docetaxel in Advanced Non...” NCT06879717 ↗ |
| Known as | MSC2360844 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3683575 ↗ |
| Known as | roginolisib hemi-fumarate | “A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 \[roginolisib hemi-fumarate\]) in combination with dostarlimab with or without docetaxel in Advanced Non...” NCT06879717 ↗ |
| Action | Inhibit | “A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers” NCT04328844 ↗ |
| Modality | Small molecule | — CHEMBL3683575 ↗ |
| Route | Oral | “IOA-244 will be administered orally once daily (QD)” NCT04328844 ↗ |