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Dicloguamine (IRSOGLADINE)
Dicloguamine (generic name: IRSOGLADINE) is a drug. It is currently in Phase 2 development.
Dicloguanine works by binding to a specific target, altering its function to produce a therapeutic effect.
Dicloguanine, also known as IRSOGladine, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it is not known if it is FDA approved or off-patent. The approved indications for Dicloguanine are also unknown. As a small molecule, it is likely to be administered orally, but its pharmacokinetic properties, such as half-life and bioavailability, are not well-documented. Further research is needed to understand the safety and efficacy of Dicloguanine.
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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 | IRSOGLADINE |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells have locks on them, and Dicloguanine has a key that fits into one of those locks. When it binds, it changes the way the lock works, allowing the cell to function differently. This can help treat various conditions by changing the way cells behave.
Approved indications
Common side effects
Key clinical trials
- Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population (PHASE4)
- [KJ-INT-002] BE Study (PHASE1)
- A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet (PHASE1)
- The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers (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:
- Dicloguamine CI brief — competitive landscape report
- Dicloguamine updates RSS · CI watch RSS
Frequently asked questions about Dicloguamine
What is Dicloguamine?
How does Dicloguamine work?
What is the generic name of Dicloguamine?
What development phase is Dicloguamine in?
Related
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing