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SP-2577 Seclidemstat
SP-2577 Seclidemstat is a Small molecule drug developed by Salarius Pharmaceuticals, LLC. It is currently in Phase 1 development. Also known as: LSD1 Inhibitor.
Seclidemstat, also known as SP-2577, is a small molecule that has been studied in clinical trials for various conditions, including Ewing Sarcoma, Myxoid Liposarcoma, and others. It is an LSD1 inhibitor, as indicated by its use in a rollover protocol to allow continued access to the LSD1 inhibitor Seclidemstat (SP-2577).
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | SP-2577 Seclidemstat |
|---|---|
| Also known as | LSD1 Inhibitor |
| Sponsor | Salarius Pharmaceuticals, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (PHASE1, PHASE2)
- Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas (PHASE1)
- A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577) (PHASE1, PHASE2)
- Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers (PHASE1)
- Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SP-2577 Seclidemstat CI brief — competitive landscape report
- SP-2577 Seclidemstat updates RSS · CI watch RSS
- Salarius Pharmaceuticals, LLC portfolio CI
Frequently asked questions about SP-2577 Seclidemstat
What is SP-2577 Seclidemstat?
Who makes SP-2577 Seclidemstat?
Is SP-2577 Seclidemstat also known as anything else?
What development phase is SP-2577 Seclidemstat in?
Related
- Manufacturer: Salarius Pharmaceuticals, LLC — full pipeline
- Also known as: LSD1 Inhibitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing