Last reviewed · How we verify
Arestal (LOPERAMIDE OXIDE)
Arestal (generic name: LOPERAMIDE OXIDE) is a loperamide oxide drug. It is currently in Phase 2 development.
Arestal works by binding to opioid receptors in the gut to slow down bowel movements.
Arestal, also known as Loperamide Oxide, is a small molecule drug of the loperamide class. Its mechanism of action and approved indications are not well-documented. As a result, there is limited information available on its commercial status, safety considerations, or pharmacokinetic properties. Further research is needed to fully understand Arestal's characteristics and potential applications. Its development history is also unclear.
-
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 | LOPERAMIDE OXIDE |
|---|---|
| Drug class | loperamide oxide |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 2 |
Mechanism of action
Imagine your gut is like a highway, and Arestal is like a traffic cop that slows down the traffic. By doing so, it helps to reduce diarrhea and other symptoms associated with irritable bowel syndrome (IBS). This is achieved by reducing the movement of food through the digestive system.
Approved indications
Common side effects
- Mydriasis
Key clinical trials
- Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan (PHASE2)
- CASAD for Severe Diarrhea in the Emergency Department (NA)
- Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research (PHASE2)
- The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit (NA)
- Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection (PHASE2)
- The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer (PHASE1,PHASE2)
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:
- Arestal CI brief — competitive landscape report
- Arestal updates RSS · CI watch RSS
Frequently asked questions about Arestal
What is Arestal?
How does Arestal work?
What is the generic name of Arestal?
What drug class is Arestal in?
What development phase is Arestal in?
What are the side effects of Arestal?
Related
- Drug class: All loperamide oxide drugs
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing