Drugs / Resminostat
Resminostat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Kinselby | primary cutaneous T-cell lymphoma | 2024-03-01 | “In February 2024, 4SC AG submitted its Marketing Authorisation Application (MAA) for resminostat in advanced CTCL to the European Medicines Agency (EMA)” 4sc.com ↗ “announced today that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA)” 4sc.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04955340 | Oct 2021 → Jan 2022 | Sezary syndrome, mycosis fungoides | 4SC AG | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02400788 | Apr 2013 → Jun 2016 | hepatocellular carcinoma | Yakult Honsha Co., LTD | Completed | No outcome recorded |
| Phase 1/2 | NCT01277406 | Jan 2011 → Feb 2013 | colorectal carcinoma | 4SC AG | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT02953301 | Nov 2016 → Mar 2023 | Sezary syndrome, mycosis fungoides | 4SC AG | Completed | Met primary |
| Phase 2 | NCT01037478 | Dec 2009 → Jan 2012 | Hodgkins lymphoma | 4SC AG | Completed | No outcome recorded |
| Phase 2 | NCT00943449 | Jul 2009 → Jun 2012 | hepatocellular carcinoma | 4SC AG | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | 4SC AG | Regulatory Resminostat (Kinselby) received a Negative CHMP Opinion in the EU 4sc.com ↗ |
| 2025-05-20 | 4SC AG | Regulatory EMA signals a Negative CHMP Opinion on the Marketing Authorization Application for Resminostat (Kinselby) 4sc.com ↗ |
| 2025-04-28 | 4SC AG | Regulatory 4SC announces further EMA feedback relating to Resminostat’s (Kinselby) Marketing Authorisation Application 4sc.com ↗
4SC has been invited to an Oral Explanation before the Committee for Medicinal Products for Human Use (CHMP) at its end of May meeting. |
| 2025-03-03 | 4SC AG | Regulatory 4SC Announces EMA’s Feedback relating to Resminostat’s (Kinselby) Marketing Authorisation Application 4sc.com ↗
the application for resminostat (Kinselby) an orphan medicinal product for the treatment of patients with CTCL is currently not approvable since “major objections” preclude a recommendation for marketing authorisation at this stage |
| 2024-07-16 | 4SC AG | Regulatory 4SC receives Orphan Drug Status (ODS) for resminostat (Kinselby) in cutaneous T-cell lymphoma in Switzerland 4sc.com ↗
Swissmedic has granted Orphan Drug Status for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) |
| 2024-04-15 | 4SC AG | Regulatory 4SC AG: Paediatric Investigation Plan waiver for resminostat from the UK MHRA received 4sc.com ↗ |
| 2024-04-11 | 4SC AG | Results 4SC: Landmark RESMAIN study data presented at the 5th World Congress of Cutaneous Lymphomas 4sc.com ↗
The median time to next treatment (median TTNT) showed a significant improvement for resminostat (Kinselby) versus placebo, more than doubling to 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.428, 0.825) |
| 2024-03-01 | 4SC AG | Regulatory 4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby) 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination. |
| 2023-10-18 | 4SC AG | Regulatory 4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union 4sc.com ↗
The European Medicines Agency (EMA) has granted Orphan Drug Designation for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) |
| 2023-09-27 | 4SC AG | Regulatory 4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA 4sc.com ↗ |
| 2023-09-25 | 4SC AG | Results 4SC: Landmark RESMAIN study data presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 4sc.com ↗
Resminostat (Kinselby) as a maintenance treatment for advanced CTCL, is clinically proven to postpone disease progression in patients – a new treatment paradigm in CTCL |
| 2023-06-19 | 4SC AG | Regulatory 4SC AG – Resminostat Marketing Application Proceeding & Kinselby accepted as Tradename 4sc.com ↗
The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA) and rapporteurs are expected to be appointed in July 2023 |
| 2023-05-31 | 4SC AG | Regulatory Resminostat: 4SC Filed Letter of Intent to the European Medicines Agency (EMA) 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) has now filed with EMA its letter of intent to file for Marketing Authorization for resminostat in cutaneous T cell lymphoma (CTCL) and request the appointment of rapporteurs. |
| 2023-05-23 | 4SC AG | Results 4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL) 4sc.com ↗
Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo |
| 2023-01-11 | 4SC AG | Regulatory European Medicines Agency Accepts 4SC’s Eligibility Request for Resminostat in Cutaneous T cell Lymphoma (CTCL) 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced that its pre-authorisation eligibility request to the European Medicines Agency (EMA) for resminostat in cutaneous T cell lymphoma had been accepted. |
| 2021-06-16 | 4SC AG | Results 4SC – Resminostat and RESMAIN Study Update 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol. |
| 2019-09-27 | 4SC AG | Results Key resminostat scientific data to be presented at EORTC-CLTF meeting in Athens 4sc.com ↗
Resminostat treatment of CTCL cell lines reduces the level of IL-31 sustainably, indicating a potential to reduce itching in CTCL patients and thereby to improve their health-related quality of life. |
| 2018-06-28 | 4SC AG | Results New data supports resminostat’s mechanism of action in CTCL maintenance therapy 4sc.com ↗
New preclinical data of 4SC AG (4SC, FSE Prime Standard: VSC) demonstrates that resminostat impacts the expression of a number of genes underlying the key biological mechanisms of cutaneous T-cell lymphoma (CTCL, a blood cancer affecting the skin). |
| 2018-01-31 | 4SC AG | Results Positive DSMB safety review of 4SC’s pivotal RESMAIN study of resminostat in CTCL 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol. |
| 2017-12-20 | 4SC AG | Regulatory 4SC receives Pediatric Investigation Plan Waiver for resminostat in CTCL from the European Medicines Agency 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced that it received a Pediatric Investigation Plan waiver from the European Medicines Agency (EMA) for resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL). |
| 2017-10-10 | 4SC AG | Results Resminostat demonstrates potential to significantly alleviate itching in CTCL patients 4sc.com ↗
Resminostat reduces the expression of IL-31 – a messenger molecule which is associated with itching in patients with cutaneous T-cell lymphoma (CTCL) |
| 2017-09-13 | 4SC AG | Results Phase I study of 4SC’s resminostat indicates efficacy in biliary tract cancer 4sc.com ↗
We observed tumor shrinkage or disease stabilization in all patients with biliary tract cancer receiving second-line study treatment according to the recommended regimen. |
| 2017-05-30 | 4SC AG | Results Resminostat enhances immune cell cancer cell interaction 4sc.com ↗
New preclinical data of 4SC AG (4SC, FSE Prime Standard: VSC) has demonstrated that resminostat influences the anti-cancer response of natural killer (NK) cells – a subset of our body’s own immune cells. |
| 2017-01-24 | 4SC AG | Results Overall survival benefit for resminostat in first-line liver cancer study subgroup 4sc.com ↗
Substantial increase in overall survival shown in platelet-defined patient subgroup for combination treatment with resminostat and sorafenib |
| 2016-10-05 | 4SC AG | Results Subgroup analysis suggests survival benefit in patients with advanced liver cancer treated with resminostat 4sc.com ↗
Subgroup analysis suggests survival benefit in patients with advanced liver cancer treated with resminostat |
| 2016-06-16 | 4SC AG | Results Resminostat boosts cancer immunotherapy 4sc.com ↗
Current research results of 4SC AG (4SC, FSE Prime Standard: VSC) show that due to its epigenetic mechanism of action, resminostat has the potential to be a combination partner of already approved immunotherapies for cancer and to favorably boost their efficacy. |
| 2016-05-27 | 4SC AG | Results 4SC provides headline results from Yakult Honsha’s Phase II trial of resminostat in combination with sorafenib as first line therapy in liver cancer 4sc.com ↗
In the Phase II part in 170 Asian patients with advanced HCC, resminostat in combination with sorafenib as first-line therapy in HCC did not meet the primary endpoint of statistically significant prolonged time to disease progression (TTP) compared to sorafenib monotherapy. |
| 2016-02-24 | 4SC AG | Regulatory FDA approves IND application for resminostat in liver cancer 4sc.com ↗
The FDA’s approval of our IND application is a major milestone in developing our epigenetic compound resminostat into a globally available drug for the first-line therapy of liver cancer patients. |
| 2015-10-08 | 4SC AG | Results Press Release World-renowned experts in the field of cancer therapy development discuss ‘Epigenetic Regulation of Immunogenicity’ at 10th 4SC Scientific Symposium 4sc.com ↗
The biomarker’s expression prior to resminostat treatment has been shown to correlate with patients’ overall survival in both indications. |
| 2015-03-26 | 4SC AG | Results Press Release: 4SC presents new immunotherapeutic activity data of its epigenetic cancer drug resminostat at the ECCO ITOC conference 2015 4sc.com ↗
The presentation will cover new preclinical data demonstrating immunomodulating effects of the HDAC inhibitor resminostat, thus potentially further contributing to its anti-tumoral activity, in particular enhancing response rates. |
All press releases naming this drug 52 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Resminostat | “4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma” NCT00943449 ↗ |
| Known as | 4SC-201 | “Resminostat (4SC-201)” NCT01037478 ↗ |
| Known as | BYK-408740 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4296717 ↗ |
| Known as | RAS-2410 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4296717 ↗ |
| Action | Inhibit | “HDAC Inhibitor” NCT01037478 ↗ |
| Modality | Small molecule | — CHEMBL4296717 ↗ |
| Route | Oral | “oral administration” NCT01037478 ↗ |