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SXC-2023
SXC-2023 is a Small molecule drug developed by Promentis Pharmaceuticals, Inc.. It is currently in Phase 2 development.
SXC-2023 is an orally administered drug being studied for the treatment of impulse control disorders, including trichotillomania, and cocaine-related disorders. It is a cystine–glutamate antiporter activator or glutamate modulator that is being investigated in clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | SXC-2023 |
|---|---|
| Sponsor | Promentis Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- SXC-2023 Cocaine Interaction Study (PHASE1)
- A Study in Patients With Trichotillomania (PHASE2)
- Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal (PHASE2)
- Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers (PHASE1)
- Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 (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:
- SXC-2023 CI brief — competitive landscape report
- SXC-2023 updates RSS · CI watch RSS
- Promentis Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about SXC-2023
What is SXC-2023?
Who makes SXC-2023?
What development phase is SXC-2023 in?
Related
- Manufacturer: Promentis Pharmaceuticals, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing