Drugs / vafidemstat
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04932291 | Mar 2021 → Oct 2023 | borderline personality disorder | Oryzon Genomics S.A. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03867253 Comparator | May 2019 → Nov 2020 | — | Oryzon Genomics S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2026-07-08 | Oryzon Genomics S.A. | Regulatory ORYZON announces U.S. patent grant for vafidemstat in borderline personality disorder (BPD) oryzon.com ↗ |
| 2026-02-02 | Oryzon Genomics S.A. | Regulatory ORYZON strengthens patent portfolio for vafidemstat with new Decision to Grant in Japan oryzon.com ↗
The allowed claims cover the use of vafidemstat for the treatment of aggression and social withdrawal – two symptoms associated with several CNS disorders. |
| 2025-10-17 | Oryzon Genomics S.A. | Regulatory ORYZON receives feedback from the FDA in response to the submitted Phase III protocol in Borderline Personality Disorder oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, BME: ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase III protocol to evaluate vafidemstat in borderline personality disorder (BPD). |
| 2025-06-23 | Oryzon Genomics S.A. | Regulatory ORYZON announces submission of Phase III protocol to FDA to initiate PORTICO-2 trial of vafidemstat in Borderline Personality Disorder (BPD) patients oryzon.com ↗
The submission of PORTICO-2 to the FDA marks a major step forward for Oryzon and for the field of neuropsychiatry of personality disorders, |
| 2025-04-21 | Oryzon Genomics S.A. | Regulatory ORYZON continues to strengthen its patent portfolio for vafidemstat oryzon.com ↗ |
| 2025-02-14 | Oryzon Genomics S.A. | Results ORYZON announces journal publication of final Phase IIa REIMAGINE results with vafidemstat in Psychiatry and Clinical Neurosciences oryzon.com ↗ |
| 2024-10-31 | Oryzon Genomics S.A. | Regulatory ORYZON receives Notice of allowance for patent on novel technology for measuring LSD1 target engagement oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today announced that it has received the Notice of allowance from the United States Patent and Trademark Office (USPTO) for its patent application US2022-0389478, titled “Methods to determine KDM1A target engagement and chemoprobes useful therefor”. |
| 2024-10-14 | Oryzon Genomics S.A. | Regulatory ORYZON announces formal grant of key European patent for vafidemstat oryzon.com ↗
The granted claims cover the use of vafidemstat for the treatment of aggression and social withdrawal. |
| 2024-09-23 | Oryzon Genomics S.A. | Results ORYZON presents the final data from PORTICO, a global Phase IIb vafidemstat trial in Borderline Personality Disorder (BPD), at the European College of Neuropsycopharmacology (ECNP) congress oryzon.com ↗
Vafidemstat showed favorable results over placebo in all primary and secondary efficacy endpoints, as demonstrated by T-Forest plot analysis Global Statistical Test (GST p-values) significant and consistent with a global treatment effect favoring vafidemstat |
| 2024-09-11 | Oryzon Genomics S.A. | Regulatory ORYZON receives “Intention to grant” communication for patent relating to the use of vafidemstat in Borderline Personality Disorder oryzon.com ↗ |
| 2024-07-08 | Oryzon Genomics S.A. | Regulatory ORYZON receives “Decision to grant” for two important patents for vafidemstat in Japan oryzon.com ↗
The Decision to grant is a formal communication from the JPO in which it indicates that a patent application has reached the status where it is allowed for issuance as a patent. |
| 2024-01-05 | Oryzon Genomics S.A. | Results ORYZON Announces Topline Results from Phase IIb PORTICO study of vafidemstat in Borderline Personality Disorder (BPD) oryzon.com ↗
Results across all efficacy endpoints consistently favored vafidemstat over placebo. |
| 2023-10-10 | Oryzon Genomics S.A. | Results ORYZON presents blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder oryzon.com ↗
Results obtained confirm that PORTICO enrolled a representative real-world BPD population allowing common comorbidities and concomitant medications that are typically exclusionary in other BPD trials, as well as allowed subjects to receive psychotherapy during the trial. |
| 2023-07-05 | Oryzon Genomics S.A. | Results Positive aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder oryzon.com ↗ |
| 2023-05-10 | Oryzon Genomics S.A. | Results ORYZON reports financial results and corporate update for quarter ended March 31, 2023 oryzon.com ↗
In CNS, we reported positive results from the planned interim analysis in the Phase IIb PORTICO trial with vafidemstat in Borderline Personality Disorder (BPD), with the trial being determined as non-futile and to be continued with the planned enrollment number. |
| 2023-04-03 | Oryzon Genomics S.A. | Results ORYZON announces positive results from planned interim analysis of PORTICO, a Phase 2b adaptive trial in Borderline Personality Disorder oryzon.com ↗ |
| 2022-09-16 | Oryzon Genomics S.A. | Results ORYZON to present preliminary blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder oryzon.com ↗
Blinded aggregate safety data presented at ECMH correspond to the initial randomized 43 patients (data cut-off, 30 June 2022). |
| 2022-01-04 | Oryzon Genomics S.A. | Regulatory ORYZON announces approval for Serbian arm of PORTICO, vafidemstat’s Phase IIb trial in Borderline Personality Disorder oryzon.com ↗ |
| 2021-10-13 | Oryzon Genomics S.A. | Results ORYZON presents safety and efficacy data of vafidemstat from the Phase II SATEEN trial in multiple sclerosis at ECTRIMS-2021 oryzon.com ↗
Treatment was well tolerated, and no serious adverse events were reported. |
| 2021-07-13 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval to start EVOLUTION Phase IIb trial with vafidemstat in schizophrenia oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that it has received approval from the Spanish Drug Agency (AEMPS) for its Clinical Trial Application (CTA) to conduct a Phase IIb clinical trial with vafidemstat in patients with schizophrenia. |
| 2021-07-09 | Oryzon Genomics S.A. | Results ORYZON presents safety and efficacy data of vafidemstat from the Phase II ESCAPE trial in severe CoVID-19 patients at ECCMID-2021 oryzon.com ↗ |
| 2021-06-15 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA approval of IND for PORTICO, a Phase IIb trial with vafidemstat in Borderline Personality Disorder oryzon.com ↗
ORYZON announces FDA approval of IND for PORTICO, a Phase IIb trial with vafidemstat in Borderline Personality Disorder |
| 2021-03-24 | Oryzon Genomics S.A. | Results ORYZON publishes vafidemstat first-in-human clinical trial manuscript in CNS Drugs journal oryzon.com ↗
In the trial, vafidemstat was well tolerated and did not produce any severe adverse events (SAEs) in either the Single Ascending Dose or Multiple Ascending Dose parts. |
| 2021-03-09 | Oryzon Genomics S.A. | Results ORYZON presents vafidemstat 12-month clinical data from its Phase IIa clinical trials ETHERAL and REIMAGINE-AD in Alzheimer’s at the virtual AD/PD-2021 conference oryzon.com ↗
We are pleased to report these data at AD/PD-2021, confirming the previous findings on the safety of vafidemstat in Alzheimer’s disease and its efficacy in controlling aggression and agitation. |
| 2020-11-10 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval to start PORTICO Phase IIb trial with vafidemstat in Borderline Personality Disorder oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that it has received approval from the Spanish Drug Agency (AEMPS) for its Clinical Trial Application (CTA) to conduct a Phase IIb clinical trial with vafidemstat in patients with Borderline Personality Disorder (BPD). |
| 2020-07-27 | Oryzon Genomics S.A. | Results ORYZON presents vafidemstat clinical data from its Phase IIa clinical trial ETHERAL in Alzheimer’s at the virtual AAIC-2020 conference oryzon.com ↗
This effect seems to be mainly driven by the effect in moderate AD subjects. |
| 2020-07-06 | Oryzon Genomics S.A. | Results ORYZON presents final data from its Phase IIa clinical trial REIMAGINE at the 28th European Congress of Psychiatry, EPA 2020 oryzon.com ↗ |
| 2020-06-01 | Oryzon Genomics S.A. | Results ORYZON publishes characterization and mechanism of action of vafidemstat, a Phase II clinical stage LSD1 inhibitor, in PLOS ONE oryzon.com ↗ |
| 2020-04-24 | Oryzon Genomics S.A. | Regulatory ORYZON to initiate ESCAPE: a Phase II clinical trial to test efficacy of vafidemstat in severely ill COVID-19 patients oryzon.com ↗ |
| 2020-04-03 | Oryzon Genomics S.A. | Results ORYZON presents efficacy data from its two vafidemstat clinical trials in Alzheimer’s disease at the virtual AAT-AD/PD 2020 Conference oryzon.com ↗
AD patients do not show cognitive improvement after 6 months of treatment |
| 2019-10-03 | Oryzon Genomics S.A. | Results ORYZON Presents New Positive REIMAGINE Efficacy Data of Vafidemstat in the Treatment of Aggression oryzon.com ↗
Vafidemstat reduced aggression and improved function across the three investigated psychiatric disorders, ADHD, ASD and BPD |
| 2019-09-10 | Oryzon Genomics S.A. | Results ORYZON presents new positive efficacy data on vafidemstat for treatment of aggression oryzon.com ↗ |
| 2019-07-16 | Oryzon Genomics S.A. | Results ORYZON presents data from ETHERAL Phase IIa trial at the 2019 Alzheimer's Association International Conference in Los Angeles oryzon.com ↗
Safety data so far show that vafidemstat is safe and well tolerated |
| 2019-04-08 | Oryzon Genomics S.A. | Results ORYZON to present first in human efficacy data with Vafidemstat at the 27th European Congress of Psychiatry in Warsaw oryzon.com ↗
Oryzon is presenting data from its Phase IIa clinical trial REIMAGINE at the 27th European Congress of Psychiatry (EPA 2019) in Warsaw, Poland. |
| 2019-03-11 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA Approval of IND for ETHERAL, a Phase IIa trial of the epigenetic drug Vafidemstat in Patients with mild to moderate Alzheimer’s disease oryzon.com ↗
Oryzon has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug application (IND) is now open for vafidemstat (ORY-2001) for the treatment of mild to moderate Alzheimer’s disease (AD) patients. |
| 2018-09-07 | Oryzon Genomics S.A. | Regulatory Oryzon receives approval to begin REIMAGINE: a Phase IIa clinical trial with Vafidemstat (ORY-2001) in aggressiveness oryzon.com ↗
Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today the approval by the Spanish Medicines Agency (AEMPS) of a clinical trial authorization (CTA) to carry out a Phase IIa trial with Vafidemstat (ORY-2001) in patients with episodes of aggressiveness. |
| 2018-05-29 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval in the United Kingdom to start ETHERAL: a Phase IIa clinical trial in Alzheimer’s Disease with ORY-2001 oryzon.com ↗ |
| 2018-05-08 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval in France to start ETHERAL: a Phase IIa clinical trial in Alzheimer’s Disease with ORY-2001 oryzon.com ↗ |
| 2018-04-04 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval to start ETHERAL: a Phase IIa clinical trial in Alzheimer’s Disease with ORY-2001 oryzon.com ↗ |
| 2017-11-13 | Oryzon Genomics S.A. | Results ORYZON to present new preclinical data of ORY-2001 at the Neuroscience 2017 meeting organized by the Society for Neuroscience oryzon.com ↗
ORY-2001 reduces aggression in animal models |
| 2017-10-31 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval from AEMPS to start SATEEN: a Phase IIA clinical trial in Multiple Sclerosis with ORY-2001 oryzon.com ↗
today announced that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a PhaseIIA clinical study with ORY-2001 in patients of Multiple Sclerosis (MS). |
| 2017-07-24 | Oryzon Genomics S.A. | Results ORYZON presents final data on the Phase I trial with ORY-2001 at the Alzheimer’s Association International Conference (AAIC-2017) oryzon.com ↗
Excellent safety data profile on 106 healthy volunteers |
| 2017-04-03 | Oryzon Genomics S.A. | Results ORYZON presents data on the Phase I trial with ORY-2001 at the 13th International Conference on Alzheimer’s and Parkinson’s diseases oryzon.com ↗
Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, presented last Friday preliminary data on the First in Human clinical trial of ORY-2001 at the 13th international Conference on Alzheimer’s and Parkinson’s disease celebrated in Vienna, Austria. |
| 2017-02-27 | Oryzon Genomics S.A. | Results ORYZON presented new preclinical data of ORY-2001 therapeutic activity in Multiple Sclerosis at ACTRIMS-2017 oryzon.com ↗
ORY-2001 Reduces Lymphocyte Egress and Demyelination in Experimental Autoimmune Encephalomyelitis |
| 2016-01-29 | Oryzon Genomics S.A. | Regulatory Oryzon Receives Approval in Spain to Initiate Phase I for ORY-2001 for Alzheimer’s Disease oryzon.com ↗ |
| 2015-12-16 | Oryzon Genomics S.A. | Regulatory ORYZON Files Clinical Trial Application in Spain for Phase I Study with ORY-2001 for Alzheimer’s Disease oryzon.com ↗
today announced that a Clinical Trial Application (CTA), the European IND equivalent, has been filed with the Spanish Drug Agency (AEMPS) to conduct a Phase I clinical study with healthy volunteers |
All press releases naming this drug 81 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vafidemstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04932291 ↗ |
| Known as | ORY-2001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03867253 ↗ |
| Modality | Small molecule | — CHEMBL4802155 ↗ |