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SOFALCONE
SOFALCONE is a sofalcone drug. It is currently in Phase 2 development for Gastric ulcer.
SOFALCONE works by inhibiting the production of stomach acid.
SOFALCONE is a small molecule modality used in phototherapy interventions, including effective PBMT/sMF and placebo PBMT/sMF, for various conditions such as post-stroke, muscle strength, knee pain chronic, temporomandibular disorder, and high-level rugby athletes. It has been studied in clinical trials for its effects on gait and balance in post-stroke individuals, among other conditions.
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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 | SOFALCONE |
|---|---|
| Drug class | sofalcone |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 2 |
Mechanism of action
Imagine your stomach lining is like a delicate flower. When you eat, your stomach produces acid to help break down food, but too much acid can damage the lining and cause ulcers. SOFALCONE helps by reducing the amount of acid produced, allowing the lining to heal and preventing further damage.
Approved indications
- Gastric ulcer
Common side effects
Key clinical trials
- Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis (NA)
- Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans (NA)
- Effects of Multi Radiance Medical® Super Pulsed Laser on Chronic Knee Pain (NA)
- Photobiomodulation On Muscle Recovery In Professional Soccer Players (NA)
- Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance (NA)
- Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia (NA)
- Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With COVID-19 (NA)
- Photobiomodulation Therapy on Low Back Pain (NA)
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:
- SOFALCONE CI brief — competitive landscape report
- SOFALCONE updates RSS · CI watch RSS
Frequently asked questions about SOFALCONE
What is SOFALCONE?
How does SOFALCONE work?
What is SOFALCONE used for?
What drug class is SOFALCONE in?
What development phase is SOFALCONE in?
Related
- Drug class: All sofalcone drugs
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Gastric ulcer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing