Тимоген

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Тимоген

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Тимоген

Property Description
Active ingredient Alfa-glutamyl-triptophan (Oglufanide)
Form Nasal dosed spray, Cream for external use, Solution
Pharmacological class Synthetic Dipeptide Immunomodulator / Immunoadjuvant
General purpose Support and regulation of the immune system
Origin Synthetic (oligopeptide/dipeptide)

Identity and Pharmacological Classification

Тимоген (Thymogen) is a unique pharmaceutical preparation whose core component is Alfa-glutamyl-triptophan, a chemically defined, synthetic dipeptide. This active ingredient, recognized by the International Nonproprietary Name (Oglufanide), is consistently classified as a biologic response modifier and a synthetic dipeptide immunomodulator. It is placed within the high-level pharmacological class of immunoadjuvants, highlighting its function as an agent designed to interact with and adjust the body's defensive mechanisms.


Composition and Available Forms

The structure of Тимоген is distinguished by its simplicity: the oligopeptide (dipeptide) is composed only of the two amino acids, L-glutamic acid and L-tryptophan. The synthetic origin of the molecule ensures consistency and high purity. Research on the synthetic peptide's mechanism confirms its role in modulating the immune system, specifically by influencing cellular and humoral immune responses.

Alfa-glutamyl-triptophan is made available in several pharmaceutical preparations, providing flexibility for administration. These forms include the well-known nasal dosed spray and a cream for external use, in addition to a solution form. This variety dictates the primary routes of administration, which are typically intranasal and topical/dermal, offering non-invasive delivery options for the immunomodulator.


General Purpose of This Immunomodulator

The general purpose of Тимоген is focused on maintaining immune balance and enhancing immune resilience. It acts as an immunoadjuvant to help regulate the body's innate immune response when the natural defenses are compromised. The overall benefit is to assist the immune system's efficiency, positioning the drug as a supportive element in health strategies focusing on immune function.

What side effects are possible with Тимоген?

Possible Side Effects and Safety Information

Regulatory documentation for the synthetic dipeptide Oglufanide (Alfa-glutamyl-triptophan) establishes a safety profile primarily defined by administration-agnostic safety constraints rather than an extensive list of categorized adverse drug reactions.


Official Safety Profile Overview

The primary safety restriction documented in regulatory summaries is the explicit contraindication of individual intolerance to the active substance or its components. This means the drug is specifically not authorized for use in individuals with known sensitivity to the medicine.

Official regulatory sources do not classify potential side effects using standard frequency terminology (e.g., very common, common, rare) or group them by System-Organ Class (SOC). Therefore, information on the frequency or anatomical location of possible adverse reactions is not systematically detailed in this manner within the primary regulatory summaries.

No specific severe or serious adverse reactions are explicitly described or classified as such in the core regulatory documentation.


Safety Considerations for Concomitant Use

High-level safety considerations are documented regarding the concurrent use of Oglufanide with other pharmacological agents. Authoritative government health databases note that co-administration with certain local anesthetics and related agents may increase the risk or severity of methemoglobinemia.

Furthermore, when Oglufanide is combined with erythropoietin-mimetic agents (e.g., Darbepoetin alfa), a potentially increased risk of thrombosis is documented. These instances represent safety consequences related to combined pharmacological action.

Regulatory summaries do not contain explicit safety notes for specific populations such as older adults or those with renal impairment, nor do they detail time-related safety patterns associated with treatment initiation or long-term exposure.

Overdose and Emergency Response

The official regulatory information for Timogen (Oglufanide) indicates a limited systemic toxicity profile, with experimental data documenting the drug as non-toxic at levels significantly exceeding the therapeutic dose. The primary considerations for overdose management are based on exposure context rather than severe intrinsic toxicity.

Documented clinical manifestations of overdose are typically localized and self-limiting. These signs include overt secretion of the nasal mucosa, which is associated with the intranasal formulation. A transient flu-like syndrome may also occur when the single therapeutic dose is exceeded by approximately ten-fold. For these documented symptoms, the official instructions state that active treatment is not required, as the manifestations are expected to resolve solely upon withdrawal of the drug. No specific antidote is known or documented in the regulatory labeling.

A separate regulatory requirement exists for the specific event of accidental ingestion (swallowing the preparation). In this case, official documents mandate that the individual seek immediate medical attention. The required procedural intervention described in the label for this specific context is the performance of gastric lavage (stomach washing).

Therapeutic Uses of Тимоген

Quick Facts: Therapeutic Areas

Condition Category Therapeutic Benefit
Infectious/Inflammatory Disease May support the management of acute and chronic infectious-inflammatory conditions
Surgical/Traumatic Stress May be used to support the management of complications after surgery or injury
Respiratory Health May be considered as an option in the comprehensive treatment of acute and chronic respiratory tract diseases

Тимоген is authorized in some regions for use as a supportive agent in the comprehensive treatment of various conditions. Its primary role is to offer therapeutic support in the management of specific diseases where immune function may be compromised.

The medication may be used as part of a multi-drug regimen for acute and chronic infectious-inflammatory diseases that show decreased indicators of cellular immune response. In the context of prophylaxis, it may be administered to support the body's processes during the post-traumatic or post-operative period, or during treatment involving radiation therapy, chemotherapy, or the use of massive doses of antibiotics, which can impact regeneration and immune function.

Furthermore, Тимоген may be included in the complex therapy and prevention of viral and bacterial infections, as well as acute and chronic ailments of the respiratory passages.

Eligibility and Restrictions for Use

Who Can and Cannot Use Тимоген (Oglufanide)?

The eligibility to use Тимоген (Oglufanide) is strictly defined by official regulatory documents and includes clear restrictions based on allergy, age, and physiological status.


Absolute Contraindications

Use of Тимоген is absolutely contraindicated in these patient groups, as listed in the official prescribing information:

  • Hypersensitivity: Individuals with a known allergy to the active substance, Alfa-glutamyl-triptophan, or to any component of the formulation.
  • Pregnancy and Lactation: The drug is contraindicated for use during the entire period of pregnancy and breastfeeding for most forms (nasal spray, cream, oral).

Age-Based and Condition-Based Restrictions

Eligibility is heavily dependent on age and the specific formulation used:

Formulation Minimum Approved Age
Nasal Dosed Spray ge 1 year (Note: Some older labels specify ge 7 years)
Solution for Injection ge 6 months
  • Pediatric Use: The drug is contraindicated for children below the specified minimum age for each route of administration. Adults (ge 18 years) are generally authorized for use.
  • Autoimmune Diseases: Use is not recommended or is restricted during the acute period of any autoimmune disease.
  • Oral Formulations: Specifically contraindicated in individuals under 18 years of age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Тимоген (Alfa-glutamyl-triptophan) is highly specific, documenting a constraint related to pharmacodynamic function but identifying no other medicinal product interactions.

Documented Drug-Drug Interaction

The drug is subject to a specific restriction concerning co-administration with Glucocorticosteroid medicinal products (GCS). Concurrent use with large doses of GCS is officially documented as not recommended by the national medicines authority.

Category Official Regulatory Statement
Interacting Product Class Glucocorticosteroid medicinal products (GCS)
Interaction Outcome Pharmacodynamic antagonism: The immunosuppressive effect of GCS neutralizes the immunostimulating action of Alfa-glutamyl-triptophan.
Restriction Use with large doses of GCS is not recommended (concurrent restriction).

Overall Interaction Profile

Official regulatory documents state that no other medicinal product interactions have been formally identified. The regulatory information does not document any interactions mediated by key pharmacokinetic pathways, such as Cytochrome P450 (CYP) enzymes or drug transporters (e.g., P-gp). Additionally, no specific interaction information is provided regarding co-use with food, alcohol, or herbal products.

Mechanism of Action

Molecular Target and Activation Cascade

Тимоген's mechanism of action involves the direct binding to the high-affinity T-cell surface receptor CD28, which triggers a downstream signaling cascade. This activation pathway leads to the increased production of Interleukin-2 ( IL-2) and Interferon gamma ( IFN-gamma).


Lymphocyte Profile Modulation

The drug influences the T-helper ( Th)1/ Th2 cytokine profile through the modulation of Th1 and Th2 lymphocyte responses. This activity is central to regulating the systemic immune response by shifting the balance of cell-mediated and humoral immunity.


Effect on Immune Cell Function

Beyond T-cells, Тимоген acts on Natural Killer ( NK) cells, leading to the augmentation of their cytotoxic activity. Additionally, the compound promotes the differentiation of precursor lymphocytes into mature immune cells, thereby influencing the functional immune cell count. These actions collectively define its mechanism of immunomodulation targeting specific cellular and humoral pathways.

Dosage and Administration Information

How to use Тимоген: Administration Guidelines

Тимоген (Alfa-glutamyl-triptophan, or Oglufanide) is administered through several officially documented routes, dictated by its available pharmaceutical forms. The approved administration methods are intranasal (via the metered nasal spray), intramuscular (via the solution for injection), and topical (via the cream formulation).

The standardized dosing regimen for adults (ge 14 years) outlines a 100 mu g single daily dose for intramuscular injection, typically comprising a total treatment course dose between 300 mu g and 1000 mu g. Alternatively, the nasal spray is administered 2 times a day, with one 25 mu g dose delivered into each nasal passage.

Usage is strictly defined by time-bound courses. A full therapeutic course for the injection or nasal spray typically lasts 3 to 10 days, while prophylactic use of the nasal spray may be shorter, requiring only 3 to 5 days. Treatment is characterized by cyclic use: a mandatory interval of at least one month must separate any repeated course of therapy.

Specific rules apply to pediatric patients, requiring dose adjustments based on age. For instance, children 1–6 years use the nasal spray once daily in only one nostril, while those 7–14 years use it once daily in both nostrils. Procedurally, the nasal spray device must be primed prior to initial use, and individuals are explicitly instructed not to double the next dose if a scheduled dose is missed.

Recent Clinical Evidence

Research evidence / Overview of Studies for Тимоген (Oglufanide)

Evidence for Use in Acute and Chronic Infectious-Inflammatory Conditions

Research exploring Alfa-glutamyl-triptophan was studied in research contexts evaluating conditions characterized by fluctuating or episodic manifestations, such as acute and chronic infectious-inflammatory diseases, including respiratory tract ailments. The research was evaluated in Randomized Controlled Trials (RCTs) and various observational settings. This includes studies where the compound was evaluated for prophylactic use, tracking the incidence of infections. The studies monitored outcomes related to episodic or acute changes, specifically tracking the duration of illness and how often patients experienced new episodes. Other studies monitored immunological markers, such as T-cell subsets, and reported patterns of change in these markers during the study period. Evidence is limited regarding the long-term patterns and durability of the changes measured. The results apply only to the populations studied.

Evidence for Use as Supportive Therapy Post-Intervention

Тимоген was observed in research contexts involving patients dealing with significant physiological strain or stress following major medical treatments. Studies focused on the compound in research contexts involving patients undergoing chemotherapy, radiation therapy, or massive doses of antibiotics, as well as in post-operative or post-trauma settings. Research explored outcomes monitoring physiological strain or stress, including the incidence of infectious complications and measures related to tissue processes. Findings describe patterns observed in the studies related to the evolution of the immune profile during and immediately following the medical intervention. This research is generally specialized, and long-term effects are not fully established after treatment has concluded.

What is Still Uncertain About the Research for Тимоген

Certainty remains low in areas where the evidence relies on a limited number of high-quality studies that have not been widely replicated. The research highlights what is known — and what is still uncertain — by noting that sample sizes were modest in some core studies. Furthermore, as much of the evidence describes patterns related to short-term symptom changes, the long-term effects are not fully established, and comparative evidence is lacking in several areas, particularly regarding patient-reported outcomes over extended periods.

Frequently Asked Questions (FAQ)

Common questions about Тимоген (FAQ)


Q: Is Тимоген a type of antibiotic?

According to official regulatory documents, the active substance is classified as a synthetic dipeptide immunomodulator and an immunoadjuvant. This means its primary function is described as interacting with and adjusting the body's defensive mechanisms, rather than acting as an agent that directly kills bacteria, which is the function of an antibiotic.


Q: Can Тимоген be used alongside common vitamins and supplements?

Official regulatory documents list specific restrictions for co-use with certain medicines, such as large doses of Glucocorticosteroids. However, the overall profile states that no other medicinal product interactions have been formally identified. Specific interaction information is not provided regarding co-use with herbal products or general vitamins and supplements, meaning data on these combinations is not detailed in the official profile.


Q: Are there different forms of Тимоген (e.g., spray, injection, tablets)?

The active substance is authorized in several pharmaceutical preparations, providing flexibility for administration. The authorized forms include a nasal dosed spray, a solution form (which is intended for injection), and a cream intended for external use. Official information does not list a tablet or oral capsule formulation.


Q: What should be done if a potential side effect occurs?

Consultation with a qualified healthcare professional, such as a doctor or pharmacist, is generally advised if a potential side effect or adverse reaction occurs. This allows for proper evaluation of the event in the context of the individual's overall health and treatment plan.


Q: Is it possible to become dependent on using Тимоген?

Official regulatory documentation detailing the drug's safety profile does not classify the active substance, Alfa-glutamyl-triptophan, as having abuse or dependency potential. Use is strictly managed in time-bound courses followed by mandatory rest intervals.


Q: Is there a high rate of allergic reactions reported with Тимоген?

The primary safety restriction documented is the contraindication of individual intolerance or allergy to the active substance or its components. However, official regulatory summaries do not systematically detail potential side effects using standard frequency terminology (e.g., common, rare). As a result, the rate of allergic reactions is not systematically quantified or detailed in this manner.


Q: Is there any information about Тимоген interacting with pain relievers?

Regulatory documents list specific restrictions concerning co-administration with Glucocorticosteroids, local anesthetics, and erythropoietin-mimetic agents. Beyond the specific restrictions mentioned, official documents state that no other medicinal product interactions have been formally identified.


Q: What is the official description of interactions between Тимоген and heart medications?

The official regulatory profile identifies a specific constraint regarding co-use with certain pharmacological classes, such as large doses of Glucocorticosteroids. The broad statement of no other formally identified medicinal product interactions would apply generally to other drug classes, including heart medications.


Q: Is it normal to feel tired after starting Тимоген?

Official regulatory summaries do not systematically detail potential side effects using standard frequency terminology. Specific effects like fatigue or tiredness are not systematically detailed in the core safety documentation. If any new or persistent feelings occur, consultation with a healthcare provider is generally recommended.


Q: Why is Тимоген sometimes discussed in relation to viruses?

The drug's mechanism of action is described as including the increased production of Interleukin-2 and Interferon gamma ( IFN-gamma). Interferon gamma is a key cytokine, or signaling protein, that is involved in the body's natural defensive response to certain infectious agents. Furthermore, research has explored its use in infectious-inflammatory conditions.


Q: Do regulatory bodies classify Тимоген as a high-risk drug?

Official regulatory documentation does not explicitly classify the drug as a high-risk medicine. The core safety summaries establish a profile defined by specific contraindications and interactions. They do not systematically describe or classify specific severe or serious adverse reactions using standard frequency methodology.


Q: Is it true that Тимоген is sometimes used in complex recovery programs?

Research has explored the use of the compound in contexts involving patients dealing with significant physiological strain or stress following major medical treatments. This includes settings such as following chemotherapy, radiation therapy, or massive doses of antibiotics, as well as in post-operative or post-trauma settings.


Q: Are there any long-term follow-up studies on the use of Тимоген?

Research summaries indicate that evidence is limited regarding the long-term patterns and durability of measured changes after treatment has concluded. Because of these limitations, the long-term effects are not fully established.


Q: Does the time of day matter for when Тимоген is used?

Official administration guidelines specify the required number of times per day the drug should be used (e.g., single daily dose or two times a day). However, the guidelines do not mandate a specific time of day (morning, noon, or night) for administration.


Q: Why might a person be asked to use Тимоген more than once per year?

The administration guidelines specify that treatment is characterized by cyclic use. A full therapeutic course is followed by a mandatory interval of at least one month before a repeated course of therapy may be initiated. The guidelines define the conditions under which repeated courses of therapy may be initiated.


Q: Is the research on Тимоген published in peer-reviewed journals?

Research involving the active substance was evaluated in Randomized Controlled Trials (RCTs) and various observational settings. Studies of this quality, including RCTs, are typically reported in established, peer-reviewed scientific literature.


Q: Is there an established maximum period for using Тимоген continuously?

The standardized regimen defines usage in time-bound courses, which typically last between 3 to 10 days. This course must be followed by a mandatory interval of at least one month before any subsequent course can be started.


Q: Do official documents mention any effects of Тимоген on mental alertness?

Official regulatory summaries do not contain explicit safety notes detailing potential effects on mental alertness or cognitive function. The safety profile is primarily defined by contraindications and interactions with specific other medications.


Q: Is Тимоген related to any other commonly known immune medicines?

The drug is classified as a synthetic dipeptide immunomodulator due to its composition and action on immune cells. It is placed within the high-level pharmacological class of immunoadjuvants, which is a general category for agents described as adjusting the body's defensive mechanisms.


Q: Is it mentioned anywhere that Тимоген can affect blood test results?

Research studies have monitored changes in specific immunological markers, such as T-cell subsets. Official safety information also notes potential safety consequences related to combined action with certain agents (e.g., erythropoietin-mimetics).

How should Тимоген be stored and disposed of?

How to Store and Dispose of Тимоген (Timogen)

The official storage conditions for Тимоген (Oglufanide) are mandated by the national regulatory authority in the country where the product is authorized. To maintain product stability, the medicine must be stored in a dry, dark place at a temperature not exceeding 25°C (77°F).

Mandatory Storage Rules:

  • Temperature: Do not store above 25°C.
  • Protection: Must be protected from light and moisture.
  • Child Safety: Keep the medicine strictly out of the reach of children.
  • Stability: When stored correctly, the unopened lyophilisate form has a shelf-life of three years.

Disposal of any unused or expired Тимоген must be completed in accordance with local legal regulations and pharmaceutical waste management programs.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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