Oglufanide
Also known as: gamma-D-glutamyl-L-tryptophan, Oglufanide disodium, SCV-07
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Summary
Oglufanide (also known as gamma‑D‑glutamyl‑L‑tryptophan, Oglufanide disodium, SCV‑07) is an investigational immunomodulatory dipeptide that has been explored in early‑stage research. It belongs to the family of immunomodulatory and thymic peptides and is listed as a compound of interest in clinical‑trial databases, although no published efficacy or safety data are provided in the available literature.
Mechanism of Action
Synthetic dipeptide (gamma-D-glutamyl-L-tryptophan) that modulates immune function by activating T-lymphocytes and natural killer cells, enhancing cytokine production (including IL-2 and interferon-gamma), and restoring immune homeostasis in immunocompromised states.
What the Research Shows
The only peer‑reviewed references mentioning Oglufanide are a 2005 catalogue of drugs under clinical‑trial consideration, where Oglufanide appears among many investigational agents, and a 2023 chemical‑methods paper describing a metal‑free C7‑H borylation technique applied to tryptophan‑containing peptides, including Oglufanide as a substrate for late‑stage modification. Neither abstract provides pharmacological, pre‑clinical, or clinical outcome data for Oglufanide; the literature thus limits knowledge of its biological activity to its classification as an immunomodulatory dipeptide.
Limitations of the Evidence
Evidence for Oglufanide is confined to its inclusion in a drug‑listing resource and its use in a synthetic chemistry study. No pre‑clinical efficacy, pharmacodynamic, or clinical trial results are reported, leaving its therapeutic potential, optimal dosing, and safety profile undefined. The lack of mechanistic or outcome data precludes any assessment of benefit or risk.
How It Is Administered
Oglufanide has been investigated for oral and subcutaneous administration routes. Specific formulation details, dosing regimens, or pharmacokinetic parameters have not been disclosed in the cited literature, reflecting its early investigational status.
Routes of Administration
Goals & Uses
- Immunorestoration in immunodeficiencyImmunologyLow
- Hepatitis C immune modulationInfectious DiseaseModerate
- Tuberculosis adjunct therapyInfectious DiseaseLow
- Treatment of oral mucositis from radiationOncology Supportive CareModerate
Contraindications
- Organ transplant recipients on immunosuppressionTransplantModerate
- Active autoimmune diseaseAutoimmunityModerate
- Known hypersensitivity to oglufanide or its componentsAllergyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- FatigueGeneralUncommonLow energy or tiredness
- Fever/flu-like symptomsSystemicUncommon
Drug Interactions
- Interferons (e.g., pegylated interferon-alpha)Low
- Immunosuppressants (e.g., corticosteroids, cyclosporine)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Severe hepatic or renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
Regulatory Status
- European UnionUnknownNo EMA approval; limited regulatory history in EU.
- United StatesInvestigationalStudied under IND for oral mucositis and hepatitis C; no FDA approval.
- United KingdomUnknownNo MHRA approval documented.
Not approved by the FDA or EMA. Investigated under IND in the US for oral mucositis and hepatitis C. Has been used in some Eastern European countries under research or compassionate-use frameworks. No current approved indication in major Western regulatory jurisdictions.
Evidence & Sources
- Journal ArticleLowBayes M, Rabasseda X, Prous JR2005-01-01T00:00:00.000000Z
- Journal ArticleLowMeena R, et al.2023-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of compound is Oglufanide?
Oglufanide is an investigational immunomodulatory dipeptide, also referred to as gamma‑D‑glutamyl‑L‑tryptophan. It is classified within the family of immunomodulatory and thymic peptides, but its precise biological actions have not been detailed in the available studies.
Has Oglufanide been tested in clinical trials?
The 2005 reference lists Oglufanide among many compounds under clinical‑trial consideration, but it does not provide results or trial designs. No published clinical efficacy or safety data for Oglufanide are available from the cited literature.
What is known about the mechanism of Oglufanide?
The abstracts do not describe any mechanism of action. While it is categorized as an immunomodulatory peptide, specific receptors, pathways, or cellular effects have not been reported in the cited sources.
Are there any safety concerns with Oglufanide?
No safety or adverse‑event information is presented in the referenced abstracts. Consequently, potential risks, tolerability, or contraindications remain unknown at this stage of investigation.
How is Oglufanide administered in research settings?
Research mentions oral and subcutaneous routes for Oglufanide. Details on formulation, dosage, or administration protocols have not been disclosed, reflecting its status as an investigational compound without approved therapeutic use.
What is Oglufanide used for?
Oglufanide is educationally associated with: Immunorestoration in immunodeficiency, Hepatitis C immune modulation, Tuberculosis adjunct therapy, Treatment of oral mucositis from radiation. Educational only — not medical advice.
How is Oglufanide administered?
Recorded routes of administration: Oral, Subcutaneous.
What are the potential side effects of Oglufanide?
Reported adverse effects include: Injection site reactions, Nausea, Fatigue, Fever/flu-like symptoms. This list is not exhaustive — consult a qualified clinician.
Who should avoid Oglufanide?
Recorded contraindications: Organ transplant recipients on immunosuppression, Active autoimmune disease, Known hypersensitivity to oglufanide or its components. Consult a qualified clinician before use.