Approved drugImmune modulator (synthetic thymic dipeptide)

Thymogen

Oglufanide, IM862, Timogen; alpha-glutamyl-tryptophan (Glu-Trp, EW)

Common dose: 100 mcg daily for 3–10 days
Cycle: 2-week course, about every 1 months
Form: Ready-made product

A two-amino-acid peptide (glutamic acid joined to tryptophan) first isolated from the calf thymus extract Thymalin and now made synthetically. Russian labels describe it as an immune stimulant that normalizes T-cell numbers and supports tissue repair.

Evidence. Registered in Russia as an injection, nasal spray and cream for immune support in infections and after surgery, chemotherapy or radiation, and as an oral gel for atrophic gastritis. Most supporting studies are small Russian reports, many neither randomized nor blinded. As IM862 it failed placebo-controlled US cancer trials, including a 202-person phase 3 in AIDS-related Kaposi sarcoma (2005).

What it’s used for

Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.

Infections with weakened immunity: LabelRegistered in Russia (injection) as an add-on for viral and bacterial infections with suppressed immunity, such as hepatitis, pneumonia, skin infections, burns and wound infections. Supporting studies are mostly small and Russian.
Colds, flu and other airway infections: LabelThe Russian nasal spray is registered to prevent and treat upper airway infections. A 1993 study in a military unit reported fewer infections, but its abstract gives no numbers.
Immune recovery after surgery, chemotherapy or radiation: LabelRegistered in Russia for this. A small Russian placebo-controlled study in older patients before cancer surgery reported fewer complications, but its abstract gives no numbers.
Chronic atrophic gastritis: LabelAn oral gel form is registered in Russia for this. In a placebo-controlled trial, stomach glands per mm² rose 26.1% from baseline, significantly more than with placebo.
AIDS-related Kaposi sarcoma: TrialNot effective: in a 202-person placebo-controlled phase 3 trial of the IM862 nose drops, responses were 23% vs 21%, and tumors progressed sooner (median 16 vs 35 weeks).
Prostate and kidney cancer: TrialNot effective: as IM862 it didn’t slow disease progression vs placebo in 71 men with prostate cancer, and none of 25 people with kidney cancer had a tumor response.
Anti-aging and cancer prevention: AnimalUnproven in people: in female rats, monthly courses lowered tumor rates after radiation exposure and lengthened life (Anisimov 1992). No human study has tested this.

Label: an approved use. Trial: tested in people, with the result. Animal: cell or animal studies only.

Every compound’s uses, by body system: evidence map, and by condition: conditions A to Z.

Status

Approval: Approved in Russia: injection (prescription), nasal spray (non-prescription) and cream, plus an oral gel for atrophic gastritis. Not approved in the US or EU; as IM862 (oglufanide) it failed US trials in the 2000s.
Approval history: 2009Russia: Thymogen nasal spray: registration certificate dated June 10, 2009
2011Russia: Thymogen 100 mcg/mL injection: registration LS-002304 issued
2022Russia: Thymogen nasal spray: re-registered under Eurasian Economic Union rules, without expiry
2023Russia: Thymogen injection: re-registered under Eurasian Economic Union rules, without expiry
2024Russia: Regastim Gastro, an oral gel form: re-registered for chronic atrophic gastritis
US compounding: Not nominated: oglufanide isn’t on FDA’s 503A or 503B bulk lists or in any of FDA’s bulk-substance categories (503A categories updated May 14, 2026).
European Union: No marketing authorization; Thymogen is registered in Russia, not in the EU.
United Kingdom: No marketing authorization (MHRA).
Canada: No marketing authorization; no Thymogen or oglufanide product is listed in Health Canada’s Drug Product Database.
Australia: No marketing authorization. Neither Thymogen nor oglufanide is named in the Poisons Standard (October 2026).
Sport (WADA 2026): Not banned in sportNot named on the 2026 list. S0 doesn’t apply because it’s a registered medicine in Russia, and it isn’t a hormone or growth factor covered by S2.

Category 2 is FDA’s list of bulk substances that may present significant safety risks in compounding. The 503A bulks list adds substances that pharmacies may compound with. Advisory committee votes are advice; FDA makes the final decision. Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.

How it works

LabelBased on the product label.

Not known

No receptor or target is known; the label describes effects, not a mechanism. Whether a few micrograms given by nose or injection change immunity in a way that matters for patients hasn’t been shown outside small Russian studies.

Protocol

Label

Russian label

Injection: 100 mcg into a muscle once daily for 3–10 days; repeat courses at least 1 month apart, up to 4 a year.

Label

Russian label

Nasal spray: 1 spray (25 mcg) in each nostril twice daily, for 10 days to treat or 3–5 days to prevent infection.

Trial

Noy 2005

As IM862: 5 mg into the nose every other day for up to 24 weeks in AIDS-related Kaposi sarcoma; no better than placebo.

Frequency: Once daily (injection) or twice daily (spray) during a course
Route: Intramuscular injection or nasal spray (label); oral gel for gastritis (label); nose drops in US trials
Cycle: A 3–10 day course; the labels allow a repeat after at least 1 month, and up to 4 injection courses a year.
2-week course, about every 1 months, shown over 26 weeks

Common protocols

The ways Thymogen is most often run, each tagged with where it comes from.

Label injection course

Label

Dose: 100 mcg IM
How often: Once daily
How long: 3–10 days

Repeat no sooner than 1 month later; up to 4 courses a year (Russian label).

Label nasal spray course

Label

Dose: 25 mcg per spray, 1 spray in each nostril (100 mcg a day)
How often: Twice daily
How long: 10 days to treat; 3–5 days to prevent

Sold without a prescription in Russia. Repeat no sooner than 1 month later.

Oral gel for gastritis (Regastim Gastro)

Label

Dose: 3 g of powder (about 1 mg of peptide) in water
How often: Twice daily on an empty stomach
How long: 28 days

Registered in Russia for chronic atrophic gastritis; prescription only.

IM862 trial (US)

Trial

Dose: 5 mg into the nose
How often: Every other day
How long: Up to 24 weeks

Phase 3 in AIDS-related Kaposi sarcoma: responses 23% vs 21% on placebo; not effective.

Taking it

Where it goes

Injection into a muscle (label), or a spray into each nostril. The labels don’t cover injection under the skin.

If you miss a dose

The labels give no missed-dose rule. For a short daily course, resume the next day and don’t double up.

Missed doses for every compound

What to expect

During a 3–10 day course
Label uses: immune support during infections, after surgery or injury, and during chemotherapy or radiation. The label doesn’t describe effects you’d feel.
Label
Weeks 8–24 (IM862, Kaposi sarcoma)
Responses were 23% vs 21% on placebo, and tumors progressed sooner (median 16 vs 35 weeks).
Trial
After an oral course (gastritis)
In a placebo-controlled trial, stomach glands per mm² rose 26.1% from baseline, a significant gain over placebo.
Trial

Side effects and what to do

Allergic reaction (the only side effect the injection label lists)

Stop. Hives, face or throat swelling or trouble breathing needs emergency care.

Allergic rhinitis: runny, itchy or stuffy nose (spray label)

Heavy nasal discharge is also the spray’s overdose sign and stops when the spray is stopped.

Mild, brief headache, tiredness, tingling and nausea (IM862 nasal trial, 44 people)

Reported as mild and short-lived; no effects on blood counts were seen.

Loose stools (oral gel label)

Listed for the gastritis form only.

Stop and get medical help

Stop and get emergency care for hives, swelling of the face or throat, or trouble breathing (labels).

Can it cause …?

The side effects people ask about most, answered one by one. Each answer says where it comes from.

Tiredness: TrialMild, brief tiredness was reported in a 44-person IM862 nasal trial; the Russian labels don’t list it.
Headache: TrialMild, brief headache was reported in a 44-person IM862 nasal trial; the Russian labels don’t list it.
Nausea or vomiting: TrialMild, brief nausea was reported in a 44-person IM862 nasal trial; the Russian labels don’t list it.
Diarrhea or constipation: LabelLoose stools are listed for the oral gastritis form. The injection and spray labels list no gut effects.
Acne, rash or skin changes: LabelAllergic reactions, the only side effect the injection label lists, can cause rash or hives. Tingling was reported in a US nasal trial.
Water retention or swelling: LabelFluid retention isn’t listed. Allergic reactions, the label’s only listed side effect, can cause face or throat swelling, which needs urgent care.
Cancer risk: TrialIn a phase 3 Kaposi sarcoma trial, tumors progressed sooner on IM862 than placebo (16 vs 35 weeks). The oral form’s label rules out use with cancer.
DizzinessTrouble sleepingHair lossJoint or muscle painAnxiety, low mood or irritabilityLow or high blood sugarFast heartbeat or blood pressure changesMore hunger: Not reportedNot listed in the Russian labels or reported in the US nasal trials (over 300 people, up to 24 weeks).
Liver strainKidney problems: Not reportedNot listed in the Russian labels. The US nasal trials reported no significant or grade 2–3 drug toxicity.

Label: from the prescribing information. Trial: reported in human studies. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.

Who should avoid it

What its label rules out or warns about, most important first.

Allergy to alpha-glutamyl-tryptophan: LabelRuled out by the Russian labels; allergic reactions, plus allergic rhinitis with the spray, are the only side effects they list.
Babies under the labels’ minimum age: LabelThe injection label covers children from 6 months; the spray label rules it out under 1 year.
Pregnancy or breastfeeding: LabelThe spray label cites insufficient data and the injection leaflet leaves use to a doctor’s judgment of benefit over risk; the oral gastritis form rules out both.
Anyone with active cancer: LabelThe oral gastritis form’s label rules it out in cancer. As IM862 it failed a phase 3 Kaposi sarcoma trial, where tumors progressed sooner than on placebo.
Acute stomach or duodenal inflammation (oral form): LabelThe oral gel’s label lists acute inflammatory disease of the stomach and duodenum as a contraindication.

Interactions

Only interactions stated on a product label or measured in a human study are listed.

Chemotherapy (cytostatics), antibiotics and radiation therapy: LabelThe nasal spray label says Thymogen increases their effectiveness; it’s registered as an add-on to correct immune suppression during these treatments.
High-dose corticosteroids (for example prednisolone, dexamethasone): LabelThe spray label advises against using them together, because large steroid doses cancel its immune-stimulating effect.

Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.

Special situations

What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.

Pregnancy: LabelThe spray label cites insufficient clinical data and allows use only if a doctor judges the benefit outweighs the risk; the injection leaflet leaves it to the doctor. The oral gastritis form is ruled out.
Breastfeeding: LabelThe injection and spray labels allow use only on a doctor’s judgment of benefit over risk. The oral gastritis form is ruled out while breastfeeding.
Kidney problems: LabelThe labels give no warnings or dose changes for kidney disease. Enzymes split it into two ordinary amino acids, glutamic acid and tryptophan.
Liver problems: LabelThe labels give no warnings or dose changes for liver disease.
Older adults: TrialThe labels set no separate dose. A small Russian placebo-controlled study gave it by nose to older patients before cancer surgery and reported fewer complications.
Children and teens: LabelApproved in Russia for children: the injection from 6 months and the spray from 1 year, with doses by age. The oral gastritis form is for adults only.
Surgery and anesthesia: LabelThe injection is registered for use before planned surgery and after operations to support immunity; the labels list no anesthesia interactions. Tell the surgical team about it.

Label: what the prescribing information says. Trial: from human studies. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.

Tracking and pairing

Worth tracking

Signs of allergic reaction (label caution)

Often paired with

Usually run on its own.

Human studies

5 key published human studies, with how many people took part. Animal studies aren’t listed here.

2005202 people

Responses were 23% vs 21% on placebo (not significant), and median time to progression was shorter: 16 vs 35 weeks.

Design
Randomized double-blind placebo-controlled phase 3 trial (IM862), AIDS-related Kaposi sarcoma
Dose
5 mg into the nose every other day
Length
24 weeks

Noy et al., J Clin Oncol 2005, PMID 15598977
200771 people

Disease progressed in 41% on IM862 vs 49% on placebo by 6 months (p=0.39); no significant toxicity.

Design
Randomized double-blind placebo-controlled trial (IM862) added to hormone therapy, prostate cancer with rising PSA
Dose
Into the nose daily (dose not given in abstract)
Length
6 months

Mao et al., Prostate 2007, PMID 17879948
2023116 people

Stomach glands per mm² rose 26.1% from baseline (p=0.028), significantly more than with placebo (p=0.026).

Design
Multicenter randomized double-blind placebo-controlled trial of an oral form, chronic atrophic gastritis with H. pylori (biopsies analyzed)
Dose
Oral gel (dose not given in abstract)

Baryshnikova et al., Arkh Patol 2023, PMID 37272441
200044 people

36% had major responses; side effects were mild, brief headache, tiredness, tingling and nausea.

Design
Randomized comparison of two IM862 schedules, no placebo, AIDS-related Kaposi sarcoma
Dose
5 mg nose drops, 5 days on and 5 off, or every other day
Length
Until progression

Tulpule et al., J Clin Oncol 2000, PMID 10673512
200425 people

No objective responses: 8 had stable disease and 17 progressed. No grade 2–3 drug toxicity; blood VEGF fell.

Design
Open-label phase 2 trial (IM862), metastatic kidney cancer
Dose
20 mg into the nose 3× daily
Length
8-week cycles

Deplanque et al., Br J Cancer 2004, PMID 15354209

All human studies on Vial Guide

Trials under way

No ongoing trial of Thymogen is registered, and none has finished recently without publishing its results. Checked on ClinicalTrials.gov, October 7, 2026. Every compound: trials under way.

Limits of the evidence

Russian registration rests mostly on small, older Russian studies, many without described controls and often from the developers and partner clinics. The rigorous trials are mixed: as IM862 it failed placebo-controlled US cancer trials (202 people with Kaposi sarcoma; 71 with prostate cancer), while a Russian placebo-controlled trial of an oral form in atrophic gastritis was positive. It isn’t approved in the US or EU.

How it’s supplied

Russian ampoules of 100 mcg/mL for injection, a nasal spray giving 25 mcg per spray, and a 0.05% cream; an oral gel powder is registered separately. Injected into a muscle once daily, or sprayed into each nostril twice daily, for 3–10 days; repeat courses at least a month apart. It’s used as supplied, so the calculator and dose log don’t apply.

Nothing to mix: the ampoules and spray come ready to use. Research vials of 20 mg are also sold; at the label’s 100 mcg dose one vial holds 200 doses, and no data cover a mixed vial kept that long.

Datasheet

Half-life: No reliable value has been published.
Type: Peptide, 2 amino acids
Molecular weight: 333.3 g/mol
Formula: C₁₆H₁₉N₃O₅
Sequence: EWAlpha-linked L-Glu-L-Trp
Storage before use: Ampoules: 0–10 °C (2023 leaflet). Nasal spray: 2–8 °C; shelf life 2 years 6 months.
After mixing or opening: Ampoules are single-use. The labels give no separate in-use period for an opened spray.

Molecule: PubChem CID 100094 (oglufanide, free acid; UNII 4RHY598T5U). Products contain the sodium salt; IM862 was the disodium salt (CID 158780, 377.3).
Storage: Label Thymogen injection leaflet (revised March 5, 2023) and nasal spray instruction (RLS, February 1, 2021)

Every compound side by side: the half-life chart and the storage chart.

Identifiers

DrugBank: DB05779
CAS number: 38101-59-6 (oglufanide); 237068-57-4 (disodium salt)
UNII (FDA): 4RHY598T5U (oglufanide); Q60AU1LLNU (sodium salt)
PubChem CID: 100094 (oglufanide); 158780 (disodium salt)
ATC code: L03AX (other immunostimulants), per the Russian label
Development codes: IM862 (IM-862); NSC-334073; EW dipeptide
Brand names: Thymogen (Timogen) injection, nasal spray and cream; Regastim Gastro oral gel; also in Cytovir-3 capsules (all Russia)
First described: Isolated from the calf thymus extract Thymalin by Vladimir Morozov and Vladimir Khavinson’s Soviet group; PubMed reports begin in 1989.

Every compound’s numbers: the identifiers table.

Product form and quality

Alpha-L-glutamyl-L-tryptophan, used as its sodium salt (IM862 was the disodium salt). Thymodepressin, a Russian immunosuppressant, is a different isomer (gamma-D-Glu-D-Trp) with the opposite effect. Research vials (often 20 mg) have no regulated standard.

Cautions

Allergic reactions are the only side effect the injection label lists; the spray label adds allergic rhinitis.
The spray label advises against combining it with high-dose corticosteroids, which cancel its effect.
As IM862 it didn’t beat placebo in a US phase 3 Kaposi sarcoma trial, and tumors progressed sooner.
Most supporting studies are small, older and Russian; it isn’t approved in the US or EU.

Questions

What is Thymogen?

How does Thymogen work?

Thymogen is glutamic acid joined to tryptophan, a dipeptide its makers isolated from the calf thymus extract Thymalin. The Russian label says it regulates cell-based and antibody immunity, normalizes the numbers and ratio of helper and cytotoxic T cells in immune deficiency, and stimulates tissue repair when it’s suppressed. Enzymes called peptidases split it into its two amino acids. US developers tested it as IM862 to block tumor blood-vessel growth. No receptor or target is known; the label describes effects, not a mechanism. Whether a few micrograms given by nose or injection change immunity in a way that matters for patients hasn’t been shown outside small Russian studies.

Is Thymogen FDA-approved?

Approved in Russia: injection (prescription), nasal spray (non-prescription) and cream, plus an oral gel for atrophic gastritis. Not approved in the US or EU; as IM862 (oglufanide) it failed US trials in the 2000s. Not nominated: oglufanide isn’t on FDA’s 503A or 503B bulk lists or in any of FDA’s bulk-substance categories (503A categories updated May 14, 2026).

What is the usual Thymogen dose?

From the label (Russian): Injection: 100 mcg into a muscle once daily for 3–10 days; repeat courses at least 1 month apart, up to 4 a year. Nasal spray: 1 spray (25 mcg) in each nostril twice daily, for 10 days to treat or 3–5 days to prevent infection. These are the amounts sources reference, not recommendations.

How is Thymogen given?

Injected into a muscle once daily, or sprayed into each nostril twice daily, for 3–10 days; repeat courses at least a month apart.

Who should avoid Thymogen?

Allergy to alpha-glutamyl-tryptophan: Ruled out by the Russian labels; allergic reactions, plus allergic rhinitis with the spray, are the only side effects they list. Babies under the labels’ minimum age: The injection label covers children from 6 months; the spray label rules it out under 1 year. Pregnancy or breastfeeding: The spray label cites insufficient data and the injection leaflet leaves use to a doctor’s judgment of benefit over risk; the oral gastritis form rules out both. The “Who should avoid it” section lists 2 more groups and 2 interactions.

How should Thymogen be stored?

Before mixing: Ampoules: 0–10 °C (2023 leaflet). Nasal spray: 2–8 °C; shelf life 2 years 6 months. Ampoules are single-use. The labels give no separate in-use period for an opened spray.

Is Thymogen banned in sport?

No. Not named on the 2026 list. S0 doesn’t apply because it’s a registered medicine in Russia, and it isn’t a hormone or growth factor covered by S2.

Has Thymogen been studied in people?

Yes. The human studies section lists 5 published studies. The largest, from 2005, included 202 people. Responses were 23% vs 21% on placebo (not significant), and median time to progression was shorter: 16 vs 35 weeks.

How long has Thymogen been studied in people?

Trial US phase 3: 202 people with AIDS-related Kaposi sarcoma treated for up to 24 weeks (median 19.5 weeks on IM862); a prostate cancer trial ran 6 months.

Does Thymogen come in other forms, like a pill or nasal spray?

Label Registered as an injection into muscle, a nasal spray, a cream and an oral gel; US trials used nose drops (IM862). The labels don’t cover injection under the skin.

Can you drink alcohol while taking Thymogen?

No study No data. The Russian labels don’t mention alcohol.

Can Thymogen be taken with semaglutide or tirzepatide?

No study No study has combined them. The Russian labels list no interaction with diabetes or weight-loss drugs.

What happens if you take too much Thymogen?

Label The spray label says an overdose causes heavy nasal discharge that stops when the spray stops; the injection leaflet describes no overdose symptoms. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.

Sources

Thymogen 100 mcg/mL solution for intramuscular injection, Russian patient leaflet: composition, dosing, contraindications, side effects, storage (registration LP-No.(001808)-(RG-RU) of February 13, 2023; leaflet revised March 5, 2023)
Thymogen 25 mcg/dose nasal spray, Russian instruction: indications, dosing, side effects, interactions, overdose, storage (RLS entry, February 1, 2021; registration LP-No.(000640)-(RG-RU) of March 24, 2022)
Regastim Gastro (alpha-glutamyl-tryptophan) powder for oral gel, Russian instruction; Vidal registration record LP-No.(006130)-(RG-RU) of July 4, 2024
Noy et al., IM862 in AIDS-related Kaposi sarcoma, randomized double-blind placebo-controlled phase 3 trial (J Clin Oncol 2005) PMID 15598977
Morozov and Khavinson, natural and synthetic thymic peptides, including Thymalin and Thymogen (Int J Immunopharmacol 1997) PMID 9637345
Deigin et al., Thymogen and Thymodepressin, including their Russian registrations (Int J Mol Sci 2024) PMID 38732260

For the protocol details

Thymogen injection and nasal spray, Russian labels (leaflet revised March 5, 2023; spray instruction of February 1, 2021)
Tulpule et al., randomized study of IM862 nasal solution in AIDS-related Kaposi sarcoma (J Clin Oncol 2000) PMID 10673512
Baryshnikova et al., alpha-glutamyl-tryptophan in chronic atrophic gastritis, placebo-controlled trial (Arkh Patol 2023, in Russian) PMID 37272441

For how it works, who should avoid it and the limits of the evidence

Thymogen nasal spray, Russian instruction: pharmacodynamics, pharmacokinetics, contraindications, interactions, overdose (RLS entry, February 1, 2021)
Thymogen injection, Russian patient leaflet: contraindications, pregnancy, side effects (revised March 5, 2023)
Regastim Gastro powder for oral gel, Russian instruction: contraindications and side effects
Mao et al., IM862 vs placebo with hormone therapy in prostate cancer (Prostate 2007) PMID 17879948

For uses, the side-effect questions, special situations, trials, identifiers and status outside the US

Thymogen 100 mcg/mL injection, Russian patient leaflet (registration LP-No.(001808)-(RG-RU) of February 13, 2023; revised March 5, 2023)
Thymogen 25 mcg/dose nasal spray, Russian instruction (RLS entry, February 1, 2021)
Regastim Gastro powder for oral gel, Russian instruction (Vidal registration record LP-No.(006130)-(RG-RU) of July 4, 2024)
Deplanque et al., phase 2 trial of IM862 in metastatic kidney cancer (Br J Cancer 2004) PMID 15354209
Smirnov et al., Thymogen before surgery in older patients with abdominal tumors, double-blind placebo-controlled study (Adv Gerontol 2011, in Russian) PMID 21957588
Furgal et al., Thymogen and respiratory viral infections in a military unit (Voen Med Zh 1993, in Russian) PMID 8498021
Anisimov et al., Thymogen and radiation-induced cancer in rats (Vopr Onkol 1992, in Russian) PMID 1300740
Bespalov et al., Thymogen and chemically induced tumors in rats, the earliest PubMed record (Eksp Onkol 1989, in Russian) PMID 2759010
ClinicalTrials.gov searches for thymogen, oglufanide and IM862 (October 8, 2026); PubChem CIDs 100094 and 158780; FDA Global Substance Registration System; DrugBank DB05779
Health Canada Drug Product Database search (October 8, 2026) and Australian Poisons Standard, October 2026 (F2026L01327)

By Vial Guide editorsLast reviewed October 7, 2026

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