Eflepedocokin alfa
Also known as: IL-22-IgG2-Fc, RG7880, UTTR1147A
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Summary
Eflepedocokin alfa (UTTR1147A) is an investigational IL-22 Fc fusion protein developed by Genentech/Roche. It is being evaluated for conditions involving intestinal epithelial injury and dysfunction, including graft-versus-host disease (GvHD), alcoholic hepatitis, and other mucosal inflammatory conditions. It promotes epithelial regeneration and anti-microbial peptide production.
Mechanism of Action
Eflepedocokin alfa is a recombinant fusion protein consisting of IL-22 fused to an IgG2 Fc region, acting as an IL-22 receptor agonist. It binds to the IL-22 receptor complex (IL-22R1/IL-10R2) on epithelial cells, activating JAK1/TYK2 and downstream STAT3 signaling, thereby promoting intestinal epithelial repair, barrier function, and mucosal homeostasis.
Routes of Administration
Goals & Uses
- Alcoholic hepatitisHepatologyLow
- Mucositis (chemotherapy-induced)Oncology Supportive CareLow
- Graft-versus-host disease (GvHD) treatmentImmunology / TransplantModerate
- Intestinal epithelial repairGastroenterologyModerate
- Inflammatory bowel diseaseGastroenterologyLow
Contraindications
- Known hypersensitivity to eflepedocokin alfa or Fc fusion proteinsAllergy/ImmunologyHigh
- Active malignancy with STAT3-driven tumor proliferationOncologyModerate
- Severe uncontrolled infectionInfectionModerate
Adverse Effects
- Psoriasiform skin lesionsDermatologicRare
- Injection site reactionsLocalCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- FatigueGeneralCommonLow energy or tiredness
- Elevated liver enzymes (transaminases)HepaticUncommon
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Immunosuppressants (e.g., tacrolimus, cyclosporine)Moderate
- CorticosteroidsLow
Population Constraints
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Severe hepatic impairmentOrgan ImpairmentRelative
- Patients with active colorectal or pancreatic cancerOncologyRelative
Regulatory Status
- European UnionInvestigationalNo EMA approval; clinical trials conducted in EU sites.
- United StatesInvestigationalUnder clinical investigation; no FDA approval. Orphan Drug Designation explored for GvHD.
- United KingdomInvestigationalNo MHRA approval; no separate UK regulatory designation confirmed.
Not approved by FDA, EMA, or other major regulatory agencies. Investigated in multiple Phase I/II clinical trials. Orphan Drug Designation has been explored for GvHD indications.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Eflepedocokin alfa?
Eflepedocokin alfa (UTTR1147A) is an investigational IL-22 Fc fusion protein developed by Genentech/Roche. It is being evaluated for conditions involving intestinal epithelial injury and dysfunction, including graft-versus-host disease (GvHD), alcoholic hepatitis, and other mucosal inflammatory conditions. It promotes epithelial regeneration and anti-microbial peptide production.
What is Eflepedocokin alfa used for?
Eflepedocokin alfa is educationally associated with: Alcoholic hepatitis, Mucositis (chemotherapy-induced), Graft-versus-host disease (GvHD) treatment, Intestinal epithelial repair, Inflammatory bowel disease. Educational only — not medical advice.
How is Eflepedocokin alfa administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Eflepedocokin alfa?
Reported adverse effects include: Psoriasiform skin lesions, Injection site reactions, Nausea, Fatigue, Elevated liver enzymes (transaminases), Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Eflepedocokin alfa?
Recorded contraindications: Known hypersensitivity to eflepedocokin alfa or Fc fusion proteins, Active malignancy with STAT3-driven tumor proliferation, Severe uncontrolled infection. Consult a qualified clinician before use.