Drugs / ISMIDENON
ISMIDENON
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03764462 | Dec 2018 → Jan 2019 | osteoporosis | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04478279 | Jul 2020 → Dec 2026 expected | brain cancer, breast cancer, glioblastoma, metastatic melanoma +1 | Sapience Therapeutics | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01332695 | Apr → Dec 2011 | essential tremor | Sonexa Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00842673 | Feb 2009 → Sep 2010 | Alzheimer disease | Sonexa Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00842816 | Feb 2009 → May 2011 | Alzheimer disease | Sonexa Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Sapience Therapeutics | Results Sapience Therapeutics Provides Positive Data Update from Phase 2 Trial of Lucicebtide Plus SOC in Patients with Glioblastoma at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting sapiencetherapeutics.com ↗
today announced updated positive clinical and pharmacodynamic data from its Phase 2 clinical trial of lucicebtide, a first-in-class antagonist of C/EBPβ, alone or in combination with chemoradiation standard-of-care (SOC) in patients with glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29-June 2, 2026, in Chicago and online. |
| 2025-06-02 | Sapience Therapeutics | Results Sapience Therapeutics Provides Data Update from Phase 2 Trial of Lucicebtide in Patients with Glioblastoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting sapiencetherapeutics.com ↗
today announced updated positive clinical and biomarker data from its Phase 2 clinical trial of lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, in patients with glioblastoma (GBM). |
| 2024-11-09 | Sapience Therapeutics | Results Sapience Therapeutics Presents Clinical Data on Two Lead Programs, Including ST101 Oral Presentation, at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting sapiencetherapeutics.com ↗
today announced the presentation of clinical and non-clinical results on its lead programs, ST101 and ST316, at theSociety for Immunotherapy of Cancer’s (SITC) 39 th Annual Meeting, being held November 6-10, 2024, in Houston, TX. |
| 2024-06-01 | Sapience Therapeutics | Results Sapience Therapeutics Presents Positive Clinical and Biomarker Data from ST101 Phase 2 Study in GBM at ASCO 2024 in Oral Presentation sapiencetherapeutics.com ↗
ST101’s clinical activity in GBM patients in the expansion and window-of-opportunity studies is highly encouraging, showing durable responses, a compelling survival benefit, and remodeling of the tumor microenvironment to an immune-active state. |
| 2024-04-08 | Sapience Therapeutics | Results Sapience Therapeutics Presents Three Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 sapiencetherapeutics.com ↗
These data demonstrate the ability of our lead SPEARs™, ST316 and ST101, to positively impact the tumor immune microenvironment, providing further evidence of their therapeutic promise. |
| 2024-03-05 | Sapience Therapeutics | Results Sapience Therapeutics to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 sapiencetherapeutics.com ↗
ST101, a clinical CEBPβ antagonist peptide, promotes an immune-active tumor microenvironment by multiple cellular mechanisms |
| 2023-11-17 | Sapience Therapeutics | Results Sapience Therapeutics Presents New ST101 Phase 2 Clinical Data in GBM at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting sapiencetherapeutics.com ↗
The poster summarized results from an ongoing surgical window of opportunity sub-study in newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients. |
| 2023-10-13 | Sapience Therapeutics | Results Sapience Therapeutics Presents ST101 Clinical Data and ST316 Preclinical Data at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics sapiencetherapeutics.com ↗
Single agent ST101 demonstrated clinical activity and tissue treatment effect. |
| 2023-04-14 | Sapience Therapeutics | Results Sapience Therapeutics to Present Late-Breaking Data on ST101 and ST316 at the American Association for Cancer Research (AACR) Annual Meeting 2023 sapiencetherapeutics.com ↗
These datasets demonstrate the roles of ST101 and ST316 in shifting an immune-suppressive tumor microenvironment to an immune-active state, and support evaluating both agents in coordination with immune-oncology (I/O) therapeutic strategies. |
| 2022-11-14 | Sapience Therapeutics | Results Sapience Therapeutics Announces Poster Presentation on ST101 Efficacy from Phase 2 Study in Recurrent Glioblastoma (GBM) at Society for Neuro-Oncology (SNO) Annual Meeting sapiencetherapeutics.com ↗
ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients in an ongoing Phase 2 study. |
| 2022-11-10 | Sapience Therapeutics | Results Sapience Therapeutics Presents Data on the Immune Activating Function of ST101 at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting sapiencetherapeutics.com ↗
In non-clinical studies, ST101 exposure to human peripheral blood mononuclear cells resulted in dose-dependent reduction in M2 macrophage and corresponding induction of pro-inflammatory M1 macrophage. |
| 2022-09-19 | Sapience Therapeutics | Results Sapience Therapeutics Announces Publication Showcasing the Mechanism of Action and Anti-tumor Activity of ST101, a Novel and Selective Peptide Antagonist of C/EBPβ, in Molecular Cancer Therapeutics sapiencetherapeutics.com ↗
In vivo xenograft models indicate that ST101 exposure results in potent tumor growth inhibition or regression, both as a single agent and in combination studies. |
| 2022-06-03 | Sapience Therapeutics | Results Sapience Therapeutics Presents Phase 1 Data at ASCO 2022 Including Efficacy Proof-of-Concept with ST101 in Patients with Refractory Solid Tumors sapiencetherapeutics.com ↗
Treatment with ST101 resulted in 1 confirmed partial response (PR) in a patient with cutaneous melanoma lasting more than 51 weeks and 2 patients with ongoing stable disease |
| 2022-06-02 | Sapience Therapeutics | Results Sapience Therapeutics Announces Expansion of Phase 2 Study Arm with ST101 in Patients with Recurrent Glioblastoma (GBM) Based on Confirmed Partial Response (PR) sapiencetherapeutics.com ↗
Of these 14 patients, one patient has a confirmed PR after 18 weeks of therapy, seven patients have not reached the first on-study assessment, and six patients progressed. |
| 2022-05-12 | Sapience Therapeutics | Results Sapience Therapeutics Announces Poster Presentation on ST101 Phase 1 Study Results at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022 sapiencetherapeutics.com ↗
In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. |
| 2022-05-03 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives FDA Orphan Drug Designation for ST101 for the Treatment of Advanced Melanoma sapiencetherapeutics.com ↗ |
| 2022-04-11 | Sapience Therapeutics | Results Sapience Therapeutics Presents Late-Breaking Data at AACR 2022 Demonstrating the Potential of Targeting Intracellular Interactions to Drug Well-Validated Cancer Pathways sapiencetherapeutics.com ↗
These data illustrate the potential of targeting intracellular interactions to address cancer pathways that are well-validated but have previously been considered undruggable. |
| 2021-12-15 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives FDA Fast Track Designation for ST101 for Advanced Cutaneous Melanoma sapiencetherapeutics.com ↗
This is the second FTD designation received for the ST101 program, following FTD for recurrent glioblastoma (GBM), announced in early December 2021. |
| 2021-12-06 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives FDA Fast Track Designation for ST101 for the Treatment of Recurrent Glioblastoma Multiforme (GBM) sapiencetherapeutics.com ↗
Fast Track designation for ST101 highlights this unmet need and allows us to work closely with the FDA to deliver this novel therapy to people with GBM as soon as possible. |
| 2020-06-02 | Sapience Therapeutics | Regulatory Sapience Therapeutics Announces FDA Acceptance of IND Application for ST101 in Advanced Cancer Indications sapiencetherapeutics.com ↗
Sapience also announced that ST101 has been granted orphan drug designation by the FDA for the treatment of glioma. |
| 2020-05-07 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives United Kingdom Authorization to Initiate a Phase 1/2 Trial of Lead Candidate ST101 in Advanced Cancer Indications sapiencetherapeutics.com ↗
The MHRA’s acceptance of the CTA to evaluate ST101 in patients with advanced cancer indications enables the initiation of our first clinical development program, |
All press releases naming this drug 39 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ISMIDENON | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297437 ↗ |
| Known as | AD-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03764462 ↗ |
| Known as | ST101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00842816 ↗ |
| Known as | ZSET-1446 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297437 ↗ |
| Modality | Small molecule | — CHEMBL4297437 ↗ |
| Route | Oral | “tablets for oral administration” NCT01332695 ↗ |