Drugs / Iadademstat
Iadademstat
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07113691 | Jan 2026 → Jan 2030 expected | small cell lung carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 1 | NCT06502145 | Jan 2025 → Dec 2026 expected | myelodysplastic syndrome | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 1 | NCT06514261 | Dec 2024 → Sep 2026 | acute myeloid leukemia | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT06357182 | Aug 2024 → Mar 2027 expected | acute myeloid leukemia | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05546580 | Nov 2022 → Nov 2025 overdue | acute myeloid leukemia | Oryzon Genomics S.A. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06287775 | Apr 2025 → Jul 2029 expected | small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06661915 | Aug 2025 → Dec 2027 expected | acquired polycythemia vera, essential thrombocythemia, leukemia, myeloid, accelerated-phase, myelodysplastic/myeloproliferative neoplasm +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05420636 | Dec 2022 → Jul 2025 | small cell lung carcinoma | Fox Chase Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Oryzon Genomics S.A. | Results ORYZON Presents Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia (AML) at European Hematology Association (EHA) 2026 Annual Congress oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today presented updated positive clinical data from two clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia (AML) at the 2026 European Hematology Association (EHA) Annual Congress. |
| 2026-05-14 | Oryzon Genomics S.A. | Results ORYZON reports financial results and corporate update for quarter ended March 31st, 2026 oryzon.com ↗
After a median follow-up of 6 months, the estimated 12-month overall survival rate was 74%. |
| 2026-05-13 | Oryzon Genomics S.A. | Results ORYZON to Present Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia at EHA 2026 oryzon.com ↗
In first line, iadademstat with azacitidine and venetoclax continues to show favorable safety and 100% ORR, with a composite complete remission rate (CRc) of 93% (with 79% CR), and an estimated 12-month OS of 74% |
| 2026-02-24 | Oryzon Genomics S.A. | Regulatory ORYZON receives European Medicines Agency approval to initiate a Phase II study of iadademstat in essential thrombocythemia oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that the European Medicines Agency (EMA) has authorized its Clinical Trial Application (CTA) to initiate a Phase II study of iadademstat, Oryzon’s potent and selective LSD1 inhibitor currently in clinical development in oncology and hematology, for the treatment of essential thrombocythemia (ET). |
| 2025-12-09 | Oryzon Genomics S.A. | Results ORYZON presents data for iadademstat combinations in AML at the American Society of Hematology (ASH) 67th Annual Meeting oryzon.com ↗
The combination treatment resulted in a highly encouraging ORR of 100% and a CCR rate of 90%, with 80% of patients attaining a strict CR. |
| 2025-11-04 | Oryzon Genomics S.A. | Results ORYZON announces positive clinical data of iadademstat at ASH-2025 oryzon.com ↗
Preliminary data from the ongoing Phase Ib trial combining iadademstat with azacitidine and venetoclax in newly diagnosed, unfit AML patients showed a 100% overall response rate |
| 2025-08-25 | Oryzon Genomics S.A. | Regulatory ORYZON receives European Medicines Agency approval to initiate a Phase Ib study of iadademstat in sickle cell disease oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, Ticker: ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA), the European equivalent to an IND, to initiate a Phase Ib trial of iadademstat in sickle cell disease (SCD). |
| 2024-06-14 | Oryzon Genomics S.A. | Results ORYZON presents preliminary data from ongoing Phase Ib FRIDA trial with iadademstat plus gilteritinib in relapsed/refractory FLT3-mut AML patients at EHA-2024 oryzon.com ↗
Data from the first two cohorts demonstrated that combination of iadademstat plus gilteritinib was safe and showed strong antileukemic activity |
| 2024-06-03 | Oryzon Genomics S.A. | Results ORYZON announces journal publication of final Phase IIa ALICE results with iadademstat in The Lancet Haematology oryzon.com ↗ |
| 2024-04-08 | Oryzon Genomics S.A. | Regulatory ORYZON announces U.S. FDA clearance of CTEP-CRADA Phase I/II clinical trial sponsored by NCI for iadademstat plus immune checkpoint inhibitors in 1L extensive stage Small Cell Lung Cancer 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 the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I/II trial with iadademstat plus immune checkpoint inhibitors in first line small cell lung cancer (SCLC) patients with extensive disease. |
| 2022-12-12 | Oryzon Genomics S.A. | Results ORYZON presents final data from Phase IIa ALICE trial in unfit AML patients with first-line treatment of iadademstat and azacitidine in oral presentation at ASH-2022 oryzon.com ↗
Clinical efficacy signals were robust, with an objective response rate (ORR) of 81% (22 of 27 evaluable patients); of these, 64% were complete remissions (14 CR/CRi) and 36% partial remissions (8 PR). |
| 2022-11-09 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA clearance of IND to initiate a collaborative Phase II basket study with iadademstat in R/R patients with Neuroendocrine carcinomas (NECs) 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 the FDA has approved the Investigational New Drug (IND) application to initiate a Phase II collaborative study with iadademstat in patients with relapsed/refractory high grade neuroendocrine carcinomas (NEC). |
| 2022-11-07 | Oryzon Genomics S.A. | Results ORYZON announces oral data presentation at the upcoming 64th American Society of Hematology annual conference oryzon.com ↗
These results confirm previous data in supporting a strong synergy between iadademstat and azacitidine in combination. |
| 2022-06-10 | Oryzon Genomics S.A. | Results ORYZON at EHA-2022: iadademstat 42-month ALICE data demonstrate robust efficacy in combination with azacitidine in AML oryzon.com ↗
Responses are rapid, with 91% of patients responding by end of cycle 2, and durable, with 64% of CR/CRi responses lasting more than 6 months. |
| 2022-06-08 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA Orphan Drug Designation granted to iadademstat for treatment of Small Cell Lung Cancer 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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s clinical stage LSD1 inhibitor iadademstat for the treatment of patients with small cell lung cancer (SCLC). |
| 2022-03-21 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA approval of IND for FRIDA, a Phase Ib trial with iadademstat in R/R AML FLT3mut+ patients oryzon.com ↗
ORYZON announces FDA approval of IND for FRIDA, a Phase Ib trial with iadademstat in R/R AML FLT3mut+ patients |
| 2021-12-13 | Oryzon Genomics S.A. | Results ORYZON at ASH-2021: iadademstat 36-month ALICE data demonstrate robust efficacy in combination with azacitidine in AML oryzon.com ↗
The duration of observed responses is very encouraging, with 77% of the CR/CRi lasting more than 6 months. |
| 2021-11-15 | Oryzon Genomics S.A. | Results ORYZON publishes paper in ACS Pharmacology & Translational Science supporting best-in-class performance of iadademstat in Oncology oryzon.com ↗
This set of head-to-head controlled comparisons have shown that iadademstat is clearly the most potent and selective LSD1 inhibitor among all tested clinical molecules. |
| 2021-06-11 | Oryzon Genomics S.A. | Results ORYZON presents iadademstat ALICE 30-month data at EHA-2021, confirming positive and robust efficacy in combination with azacitidine in AML oryzon.com ↗
Mean Time to Response (TTR) was only 29 days. |
| 2021-02-11 | Oryzon Genomics S.A. | Regulatory ORYZON announces FDA Orphan Drug Designation granted to iadademstat for treatment of Acute Myeloid Leukemia oryzon.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s first-in-class LSD1 inhibitor iadademstat for the treatment of patients with acute myeloid leukemia (AML). |
| 2020-12-07 | Oryzon Genomics S.A. | Results ORYZON presents new robust Phase II iadademstat efficacy data in AML at ASH-2020 oryzon.com ↗
Mean Time to Response (TTR) was only 34 days. |
| 2020-10-15 | Oryzon Genomics S.A. | Results ORYZON publishes paper in Journal of Clinical Oncology demonstrating relevance of iadademstat in leukemia oryzon.com ↗
The article describes the Phase I/IIa clinical trial, which recruited 42 patients with refractory or relapsed AML, and reports that iadademstat has a good safety profile together with signs of clinical and biological activity as a single agent. |
| 2020-09-17 | Oryzon Genomics S.A. | Results ORYZON presents efficacy and safety results of its CLEPSIDRA trial with iadademstat in ED-SCLC patients at ESMO-2020 oryzon.com ↗
The combination of the three agents, iadademstat and carboplatin-etoposide, produced encouraging signs of clinical efficacy, with an objective response rate (ORR) of 40% (4 partial remissions in 10 patients) and a mean duration of response of 4.5 months. |
| 2020-06-12 | Oryzon Genomics S.A. | Results ORYZON presents new Phase II iadademstat efficacy data in AML at EHA-2020 oryzon.com ↗
Mean Time to Response (TTR) was only 37 days in those patients who responded. |
| 2019-12-09 | Oryzon Genomics S.A. | Results ORYZON presents new efficacy data from its Phase II trial ALICE investigating iadademstat in AML oryzon.com ↗ |
| 2019-09-30 | Oryzon Genomics S.A. | Results ORYZON presents positive efficacy results on iadademstat in ED-SCLC patients at ESMO-2019 oryzon.com ↗
75% of responses in the first 8 evaluable patients treated with the triple combination of iadademstat plus carboplatin-etoposide |
| 2019-09-09 | Oryzon Genomics S.A. | Results ORYZON’s iadademstat shows efficacy signs in relapsed SCLC oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical needs, today presents the first preliminary data from CLEPSIDRA, a Phase II trial investigating iadademstat in combination with standard-of-care in relapsing small cell lung cancer (SCLC) patients. |
| 2019-06-14 | Oryzon Genomics S.A. | Results ORYZON presents preliminary dose finding results of Phase II trial with iadademstat in AML oryzon.com ↗
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today presents preliminary data from Part I (dose finding) of the Phase II trial ALICE, which investigates iadademstat in combination with azacitidine in elderly patients with acute myeloid leukemia (AML), at the 24th Congress of the European Hematology Association (EHA-2019) in Amsterdam. |
| 2019-02-06 | Oryzon Genomics S.A. | Results ORYZON Announces Publication of a relevant paper for the therapeutic development of Iadademstat (ORY-1001) in Small Cell Lung Cancer (SCLC) oryzon.com ↗
Complete and durable tumor regression occurred with Iadademstat–induced NOTCH activation in a chemoresistant PDX model |
| 2018-10-17 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval to start CLEPSIDRA: a Phase IIa clinical trial in Small Cell Lung Cancer with Iadademstat (ORY-1001) oryzon.com ↗
it has received approval of a Clinical Trial Application (CTA) |
| 2018-09-10 | Oryzon Genomics S.A. | Regulatory ORYZON receives approval to start ALICE: a Phase IIa clinical trial in AML with Iadademstat (ORY-1001) oryzon.com ↗ |
All press releases naming this drug 60 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 | Iadademstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06357182 ↗ |
| Known as | IADA | “iadademstat (IADA) when administered as part of the investigational combination” NCT06357182 ↗ |
| Known as | ORY-1001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3781751 ↗ |
| Known as | RG-6016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3781751 ↗ |
| Action | Inhibit | “Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells.” NCT06357182 ↗ |
| Modality | Small molecule | — CHEMBL3781751 ↗ |
| Route | Oral | “150 microgram PO administered” NCT05420636 ↗ |