This section highlights FDA-related milestones and regulatory updates for drugs developed by Salarius Pharmaceuticals (SLRX).
Over the past two years, Salarius Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
azacitidine and Seclidemstat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
azacitidine - FDA Regulatory Timeline and Events
azacitidine is a drug developed by Salarius Pharmaceuticals for the following indication: For Hematologic Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- azacitidine
- Announced Date:
- February 3, 2025
- Indication:
- For Hematologic Cancers
Announcement
Salarius Pharmaceuticals, Inc. announces that patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).
AI Summary
Salarius Pharmaceuticals announced that patient enrollment has resumed for its investigator-initiated Phase 1/2 clinical trial. The study evaluates the combination of seclidemstat, a novel oral reversible LSD1 inhibitor, with azacitidine for treating myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). Conducted at the University of Texas MD Anderson Cancer Center, the trial aims to build on early encouraging evidence, which showed a 43% overall response rate among patients who had limited treatment options after previous therapies. By restarting the enrollment, Salarius is set to expand the clinical data on seclidemstat, offering new hope for patients with advanced MDS and CMML. This step is an important milestone as researchers continue to explore and validate innovative treatment combinations for these challenging hematologic conditions.
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Seclidemstat - FDA Regulatory Timeline and Events
Seclidemstat is a drug developed by Salarius Pharmaceuticals for the following indication: Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Seclidemstat
- Announced Date:
- July 9, 2025
- Indication:
- Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas
Announcement
Salarius Pharmaceuticals, Inc. announces that two animal studies recently published in peer-reviewed journals provide additional insight into the role of inhibiting lysine-demethylase 1 (LSD1 or KDM1A), a well-validated target in hematologic and solid tumors.
AI Summary
Salarius Pharmaceuticals recently announced two animal studies published in respected peer-reviewed journals that provide new insights into inhibiting lysine-demethylase 1 (LSD1 or KDM1A) as a cancer treatment strategy. One study, conducted in Korea, found that LSD1 inhibitors like seclidemstat can promote astrocyte formation in rat neural stem cells, offering clues about neurodevelopment and the regulation of these cells. Another study from Boston revealed that targeting LSD1 may control the progression of pre-cancerous lesions in oral squamous cell carcinoma by affecting key signaling pathways. These findings support the idea that inhibiting LSD1 could slow or stop cancer cell growth in both blood cancers and solid tumors. Salarius is now evaluating seclidemstat, a first-in-class oral LSD1 inhibitor, in clinical studies for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML), with more updates expected later this year.
Read Announcement- Drug:
- Seclidemstat
- Announced Date:
- June 17, 2024
- Indication:
- Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas
Announcement
Salarius Pharmaceuticals, Inc. announced that investigators at the University of Texas MD Anderson Cancer Center's Leukemia department presented clinical data on seclidemstat in patients with MDS and CMML at the 2024 European Hematology Association (EHA) Hybrid Congress. The meeting was held in Madrid and virtually from June 13-16, 2024.
AI Summary
Salarius Pharmaceuticals announced that investigators from the University of Texas MD Anderson Cancer Center’s Leukemia department shared promising clinical data on seclidemstat at the 2024 European Hematology Association Hybrid Congress in Madrid and online from June 13-16, 2024. The study focused on patients with higher-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) who had failed or relapsed after using hypomethylating agents. In this early Phase 1/2 dose-escalation trial, seclidemstat was evaluated in combination with azacitidine. Out of 14 evaluable patients, a 43% overall response rate was reported, with one complete response and other significant improvements noted. The data also showed a median overall survival of 18.5 months and a median event-free survival of 7.2 months, indicating encouraging early signs of activity in a patient group with limited treatment options.
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