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Dipeptamin (ALANYL GLUTAMINE)
Dipeptamin (generic name: ALANYL GLUTAMINE) is a alanyl glutamine drug. It is currently in Phase 3 development.
Dipeptamin works by providing the body with a building block of protein, specifically the amino acids alanine and glutamine.
Dipeptamin, also known as Alanyl Glutamine, is a small molecule drug in the alanyl glutamine class. Its mechanism of action and target are unknown, and it has not been approved by the FDA for any indications. The commercial status of Dipeptamin is unclear, and it is not known whether it is patented or available as a generic. Further research is needed to determine its safety and efficacy. As a result, Dipeptamin is not currently available for clinical use.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | ALANYL GLUTAMINE |
|---|---|
| Drug class | alanyl glutamine |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Think of Dipeptamin like a puzzle piece that helps the body build and repair tissues, such as muscles and organs. It does this by providing the raw materials that the body needs to create new proteins. This can be especially important for people who are recovering from illness or injury.
Approved indications
Common side effects
- Nausea
- Elevated AST levels
- Elevated CPK levels
- Elevated temperature
Key clinical trials
- Citrullinemia for the Prediction of Enteral Nutrition Tolerance Among Critically Ill Patients (NA)
- Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) (PHASE2)
- Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours (NA)
- Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy (NA)
- Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF (PHASE3)
- Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers (NA)
- Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients (NA)
- Preoperative Immunonutrition and Cardiac Patients (PHASE2,PHASE3)
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:
- Dipeptamin CI brief — competitive landscape report
- Dipeptamin updates RSS · CI watch RSS
Frequently asked questions about Dipeptamin
What is Dipeptamin?
How does Dipeptamin work?
What is the generic name of Dipeptamin?
What drug class is Dipeptamin in?
What development phase is Dipeptamin in?
What are the side effects of Dipeptamin?
Related
- Drug class: All alanyl glutamine drugs
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing