Drugs / SEL-120 FREE BASE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | acute myeloid leukemia, high-risk myelodysplastic syndrome | 2021-04-08 | “the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation clinical trial of RVU120” ryvu.com ↗ “In April 2021 the FDA placed a partial clinical hold on our Phase Ib clinical trial of RVU120 in AML/HR-MDS patients” ryvu.com ↗ “Ryvu received the clinical hold letter from the FDA on April 8th and plans to work diligently with the agency” ryvu.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04021368 | Sep 2019 → Dec 2024 | acute myeloid leukemia, myelodysplastic syndrome | Ryvu Therapeutics SA | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05052255 | Aug 2021 → May 2025 overdue | neoplasm | Ryvu Therapeutics SA | Active not recruiting | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT06987058 | Dec 2025 → Aug 2026 overdue | acute myeloid leukemia, myelodysplastic syndrome | Ryvu Therapeutics SA | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06397313 | Sep 2024 → Jun 2026 overdue | myelofibrosis | Ryvu Therapeutics SA | Recruiting | No outcome recorded |
| Phase 2 | NCT06243458 | Sep 2024 → May 2026 overdue | myelodysplastic syndrome | GCP-Service International West GmbH | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06268574 | Jan 2024 → Feb 2026 overdue | acute myeloid leukemia, myelodysplastic syndrome | Ryvu Therapeutics SA | Active not recruiting | Missed primary |
| Phase 2 | NCT06191263 | Jan 2024 → Feb 2026 overdue | acute myeloid leukemia | Ryvu Therapeutics SA | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics presents clinical data and program update on romaciclib at the European Hematology Association Congress 2026 ryvu.com ↗
In the RIVER-81 Phase II study, romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with relapsed/refractory AML (r/r AML) after VEN-based therapy failure. |
| 2026-05-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to present clinical data on romaciclib at the European Hematology Association Congress 2026 ryvu.com ↗
Romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with relapsed/refractory acute myeloid leukemia after VEN-based therapy failure (RIVER-81). |
| 2025-12-07 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents New Clinical Data from RIVER-81 and POTAMI-61 Studies of Romaciclib (RVU120) at the 2025 ASH Annual Meeting ryvu.com ↗
romaciclib demonstrated clinical activity in AML with a 43% (3 of 7 patients) CR/CRi rate(1) at 150mg QD (once daily) and 28% (2/7) CR/CRi rate at 200mg QD romaciclib in combination with venetoclax (VEN) |
| 2025-11-03 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Announces Three Abstracts on Romaciclib Ryvu Therapeutics Announces Three Abstracts on Romaciclib (RVU120) and One Abstract on Dapolsertib (MEN1703) at the 2025 ASH Annual Meeting ryvu.com ↗
Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume and symptom reductions, supporting romaciclib’s potential role in the post-JAK inhibitor setting. |
| 2025-06-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Data on RVU120 at the European Hematology Association Congress 2025 ryvu.com ↗
MF: Early data in patients with myelofibrosis (Phase II POTAMI-61) at 12 weeks of treatment show signs of efficacy, including 3 patients with an improvement in total symptom score (TSS) and 4 patients with a spleen size reduction. |
| 2024-12-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics provides an update on RVU120 Phase II program ryvu.com ↗
One of two evaluable patients in cohort 2 achieved 50% blast reduction, while disease stabilizations and reductions of peripheral blasts were observed in patients in cohort 3. |
| 2024-06-14 | Ryvu Therapeutics SA | Results Ryvu Therapeutics presents clinical and preclinical data on RVU120 at the 2024 European Hematology Association Congress ryvu.com ↗
RVU120 as a single agent showed clinical benefit in heavily pretreated patients with AML and HR-MDS in the Phase 1 RIVER-51 study (CLI120-001). |
| 2024-05-14 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to present clinical and preclinical data on RVU120 at the 2024 European Hematology Association Congress ryvu.com ↗
Updated data from the Phase I trial of RVU120 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising clinical activity. |
| 2024-04-10 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Preclinical Data on RVU120 and Synthetic Lethality Programs at the 2024 AACR Annual Meeting ryvu.com ↗
RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical models of myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. |
| 2023-12-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Data on RVU120 at the 2023 American Society of Hematology (ASH) Annual Meeting ryvu.com ↗
Clinical activity observed in 50% of evaluable patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) treated with RVU120 monotherapy, including a complete response. |
| 2023-12-07 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Data on RVU120 at the San Antonio Breast Cancer Symposium 2023 ryvu.com ↗
Translational data demonstrate synergistic activity of RVU120 and MEK inhibitors in hormone receptor-negative breast cancer |
| 2023-11-02 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to Present Data on RVU120 at the 2023 American Society of Hematology (ASH) Annual Meeting ryvu.com ↗
Updated data from the Phase I trial of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate clinically relevant benefit in 50% of evaluable patients |
| 2023-10-23 | Ryvu Therapeutics SA | Results Ryvu Therapeutics provides an update on the progress of RVU120 Phase I studies in patients with solid tumors and AML/HR-MDS, and presents the updated development plan for RVU120 ryvu.com ↗
Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today updated clinical Phase I data from RVU120 Phase I/II study in patients with relapsed/refractory metastatic or advanced solid tumors, presented at the European Society for Medical Oncology (ESMO) Congress 2023, taking place October 20-24 in Madrid, Spain. |
| 2023-06-09 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Updated Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress ryvu.com ↗
At higher doses of RVU120, consistently high levels of target inhibition can be achieved. |
| 2023-05-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to Present Clinical and Preclinical Data on RVU120 at the 2023 European Hematology Association Congress ryvu.com ↗
Until February 2023, treatment with single-agent RVU120 has led to complete remission in one patient, an increase of hemoglobin and platelets in four patients, and bone marrow blast reduction in five patients, including in a patient with TP53 double-hit. |
| 2022-12-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Clinical and Translational Data of RVU120 and SEL24 (MEN1703) at the 2022 American Society of Hematology (ASH) Annual Meeting ryvu.com ↗
The results presented at ASH from the ongoing Phase 1b trial of RVU120 in AML and HR-MDS, are very encouraging. |
| 2022-11-23 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update ryvu.com ↗
To date, RVU120 showed a complete response and disease stabilizations in 10 patients with r/r AML and HR-MDS. |
| 2022-11-03 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Announces Multiple Presentations of Clinical and Translational Data of RVU120 and SEL24 (MEN1703) at the 2022 American Society of Hematology (ASH) Annual Meeting ryvu.com ↗
One patient achieved a complete response and 10 patients achieved disease stabilization. |
| 2022-10-26 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Updated Clinical and Preclinical Data on RVU120 at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium ryvu.com ↗
To date, we have observed four disease stabilizations in this heavily pre-treated patient group with three of those lasting more than 4 months. |
| 2022-10-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Announces Poster Presentations at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium ryvu.com ↗
We are also seeing clinical benefits with disease stabilizations in patients with relapsed/refractory metastatic or advanced solid tumors. |
| 2022-06-10 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Updated Clinical and Preclinical Data on RVU120 at the 2022 European Hematology Association (EHA) Congress ryvu.com ↗
Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced updated data from the ongoing Phase 1b dose-escalation study of RVU120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS) at the Annual European Hematology Association (EHA) 2022 Hybrid Congress, June 9-17 in Vienna, Austria. |
| 2021-12-13 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Clinical and Translational Data Updates at the 63rd American Society of Hematology Annual Meeting and the 44th San Antonio Breast Cancer Symposium ryvu.com ↗
With a data cutoff of November 16, 2021, data highlights include: A Complete Remission (CR) in an AML patient harboring mutations in DNMT3A and NPM1. |
| 2021-11-04 | Ryvu Therapeutics SA | Results Ryvu Therapeutics \u0026 Collaborators to Present Clinical and Translational Data from RVU120 and SEL24/MEN1703 at the 63rd ASH Annual Meeting \u0026 Exposition and the 44th Annual SABCS ryvu.com ↗
The preliminary signs of efficacy for RVU120 include a Complete Response (CR) in an AML patient and an erythroid response (ER) in an HR-MDS patient who had relapsed after several lines of previous treatment. |
| 2021-07-14 | Ryvu Therapeutics SA | Regulatory FDA lifts Partial Clinical Hold on Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome ryvu.com ↗
Ryvu Therapeutics (WSE:RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the U.S. Food and Drug Administration, FDA, has lifted a partial clinical hold |
| 2021-06-11 | Ryvu Therapeutics SA | Results Ryvu Therapeutics Presents Positive Phase I Data for RVU120 at the Virtual EHA Congress. Phase I/II Data for SEL24 (MEN1703) presented by development partner Menarini. ryvu.com ↗
RVU120 (CDK8/19 inhibitor): Acceptable safety profile and two clinically relevant responses were observed in the Ph I dose escalation study in the first five AML and high risk MDS patients treated: one complete response (CR) and one erythroid response |
| 2021-05-28 | Ryvu Therapeutics SA | Regulatory Ryvu Therapeutics got full approval to conduct Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors in Poland ryvu.com ↗
Following the above-mentioned approvals, Ryvu Therapeutics will be able to initiate a clinical study and start enrolling patients in Poland. |
| 2021-05-12 | Ryvu Therapeutics SA | Results Ryvu Therapeutics to Present Clinical and Translational Data from RVU120 at the Virtual 26th Annual Congress of the European Hematology Association. New clinical abstract on SEL24(MEN1703) also available. ryvu.com ↗
Presented results indicate strong erythroid differentiation potential of RVU120 in (Lin-) CD34+, that acquired genetic abnormalities resulting in arrested erythroid commitment, characteristic of many MDS (myelodysplastic syndromes) and AML (acute myeloid leukemia) subtypes. |
| 2021-04-08 | Ryvu Therapeutics SA | Regulatory Ryvu Announces Partial Clinical Hold of Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome ryvu.com ↗
No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA. |
| 2021-01-07 | Ryvu Therapeutics SA | Regulatory Ryvu Therapeutics to expand its Phase I study of SEL120 (RVU120) in patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome to Poland ryvu.com ↗
We are very pleased about the prospect of starting Ryvu’s first European clinical trial by obtaining this CTA approval in Poland. |
| 2021-01-04 | Ryvu Therapeutics SA | Regulatory Ryvu Therapeutics has submitted a new Clinical Trial Application for the conduct of a Phase I/II study of RVU120 (SEL120) in patients with solid tumors ryvu.com ↗ |
| 2020-03-28 | Ryvu Therapeutics SA | Regulatory Ryvu Therapeutics receives Orphan Drug Designation from FDA for SEL120 to treat Acute Myeloid Leukemia ryvu.com ↗
Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia (AML). |
| 2019-03-26 | Ryvu Therapeutics SA | Regulatory Selvita Announces U.S. FDA Acceptance of Investigational New Drug Application to Commence Clinical Development of SEL120 in the Treatment of Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome ryvu.com ↗ |
| 2018-11-21 | Ryvu Therapeutics SA | Results Selvita Announces Presentations on CDK8 Inhibitor SEL120 at the 60th American Society of Hematology Annual Meeting ryvu.com ↗
In murine models and patient derived xenografts, administration of SEL120 resulted in a reduced burden of leukemia cells, confirming proof of concept for clinical applications of SEL120 in acute myeloid leukemia. |
| 2018-11-08 | Ryvu Therapeutics SA | Results Selvita to Present New Data from SEL120 Program at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics ryvu.com ↗
The presentation during the symposium will feature preclinical data from Selvita’s CDK8 inhibitor program SEL120 – potential treatment of acute myeloid and lymphoblastic leukemias. |
| 2017-04-07 | Ryvu Therapeutics SA | Results Selvita researchers publish new paper on CDK8 inhibitor SEL120 in Oncotarget ryvu.com ↗
Clinical candidate compound SEL120-34A has shown strong single-agent efficacy in multiple animal models of acute myeloid leukemia, mantle cell lymphoma, colorectal cancer, breast cancer and Wilms’ tumors. |
| 2016-11-30 | Ryvu Therapeutics SA | Results Selvita presents posters at 2016 EORTC-NCI-AACR Symposium ryvu.com ↗
Whats more, SEL120-34A shows favorable pharmacokinetic profile and safety indicating high therapeutic potential. |
All press releases naming this drug 62 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SEL-120 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4225966 ↗ |
| Known as | RVU120 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06397313 ↗ |
| Known as | SE-120-34A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4225966 ↗ |
| Known as | SEL120 | “This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor” NCT04021368 ↗2“RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors” NCT05052255 ↗ “RVU120 (SEL120)” NCT06243458 ↗ |
| Known as | SEL120-34A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4225966 ↗ |
| Action | Inhibit | “a novel small molecule CDK8/19 inhibitor” NCT04021368 ↗ |
| Modality | Small molecule | “a novel small molecule CDK8/19 inhibitor” NCT04021368 ↗ |
| Route | Oral | “RVU120(SEL120) will be administered as a single oral dose every other day” NCT04021368 ↗ |
| Target | CDK8 | “a novel small molecule CDK8/19 inhibitor” NCT04021368 ↗ |