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ESRU

Meglumine acridone acetate

Other immunostimulants (local classification)

ATC code: J05AX-CYCLOFERON

Updated · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Chronic hepatitis C

Not recommended

In chronic hepatitis C, Cycloferon is not mentioned in / HCV Guidance or 2020. The standard of care is direct-acting antivirals (DAAs): sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, and other combinations achieving sustained virological response above 95 % in 8–12 weeks.

Sources

  1. EASL 2020 recommendations on treatment of hepatitis C: EASL 2020 recommendations on treatment of hepatitis C (2020)
  2. AASLD-IDSA: HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C (2023)
  3. Ter Arkh: [Efficiency of using cycloferon as part of combined therapy for chronic hepatitis C (a review of multicenter clinical trials)]. (2010)

ICD-10: B18.2 · ICD-11: 1E51.1

F

Common cold

Not recommended

URI resolves spontaneously. Symptomatic care is the only approach supported by international guidelines. 'Immunomodulator' drugs are not part of this list.

Sources

  1. Sci Rep: Meglumine acridone acetate, the ionic salt of CMA and N-methylglucamine, induces apoptosis in human PBMCs via the mitochondrial pathway. (2019)
  2. Ter Arkh: [Clinical efficacy of the immunomodulatory agent cycloferon (tablets) in viral respiratory infections: Results of a systematic review and meta-analysis]. (2017)
  3. HTA Council, DOST Philippines: Meglumine Acridone Acetate (Cycloferon) – Health Technology Assessment

ICD-10: J00 · ICD-11: CA00

F

Herpes simplex

Not recommended

First-line therapy for herpes simplex remains aciclovir, valaciclovir, and famciclovir. Cycloferon is not mentioned in international protocols.

Sources

  1. WHO: WHO Guidelines for the Treatment of Genital Herpes Simplex Virus (2016)
  2. 2024 European (IUSTI/WHO) guidelines for the management of genital herpes — PMC1: 2024 European (IUSTI/WHO) guidelines for the management of genital herpes — PMC11934026 (2024)
  3. Georgian Med News: [CLINICAL EFFICIENCY OF CYCLOFERON IN CHILDREN AND ADULTS WITH HIV AND/ OR HERPES INFECTION: SYSTEMATIC REVIEW AND META-ANALYSIS]. (2018)

ICD-10: B00 · ICD-11: 1F00.Z

F

Immune support and respiratory infection care

Not recommended

Cycloferon (meglumine acridoneacetate), marketed by Polisan, is promoted as an immunity agent and interferon inducer for colds and other infections. International clinical guidelines (, , ) do not include the drug; the , , and AEMPS have not approved it. No independent international clinical studies exist. If cycloferon was recommended, consider seeking a second opinion.

Sources

  1. Sci Rep: Meglumine acridone acetate, the ionic salt of CMA and N-methylglucamine, induces apoptosis in human PBMCs via the mitochondrial pathway. (2019)
  2. Acta Pharm Sin B: Small molecules targeting the innate immune cGAS‒STING‒TBK1 signaling pathway. (2020)
  3. Vestn Otorinolaringol: [Cycloferon efficacy in treatment of upper respiratory tract infections: systematic review and meta-analysis]. (2019)
F

Influenza

Not recommended

Cycloferon for influenza is not mentioned in , , , or CDC guidelines. Antiviral options with demonstrated efficacy in independent RCTs are oseltamivir, zanamivir, and baloxavir.

Sources

  1. Ter Arkh: [Clinical efficacy of the immunomodulatory agent cycloferon (tablets) in viral respiratory infections: Results of a systematic review and meta-analysis]. (2017)
  2. Sci Rep: Meglumine acridone acetate, the ionic salt of CMA and N-methylglucamine, induces apoptosis in human PBMCs via the mitochondrial pathway. (2019)

ICD-10: J10-J11 · ICD-11: 1E32

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

The manufacturer claims induction of interferons alpha and beta, and activation of macrophages and T-lymphocytes. The active compound is a low-molecular interferon inducer based on acridoneacetic acid, synthesised in the USSR in the 1970s. The drug is absent from the international scientific literature: Cochrane, , , and do not mention it for any claimed indication.

Safety

Contraindications

  • Hypersensitivity to any component
  • Decompensated liver cirrhosis
  • Pregnancy and breastfeeding
  • Age under 4 years

Serious adverse effects

  • No independent post-marketing safety evaluation has been performed

Common adverse effects

  • Per manufacturer label: allergic reactions

Pregnancy: can you take Meglumine acridone acetate?

Contraindicated in pregnancy.

Breastfeeding: can you take Meglumine acridone acetate?

Contraindicated during breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Cycloferon is marketed in Russia in 150 mg tablets and 12.5% injection. It is prescribed for dozens of conditions, from influenza and URI to chlamydia and neuroinfections. Such a broad spectrum is itself a marketing marker: drugs with proven efficacy carry a narrow, specific indication range.

Common myths

Myth: 'a Cycloferon shot boosts the immune system'. Fact: 'boosting immunity' is a lay notion without clinical meaning. The immune system operates on pathogen-specific responses, not on a 'stronger-weaker' axis. Non-specific stimulation is either a null effect or a risk of autoimmune reactions.

Russian practice note

Cycloferon is produced and used only in Russia by Polysan. Not registered internationally. Included in some Russian Ministry of Health guidelines. This creates divergence from international practice; an independent international evidence base does not exist.

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Frequently asked

What is Meglumine acridone acetate used for?

Meglumine acridone acetate is evaluated for the following indications with varying evidence strength: Immune support and respiratory infection care (evidence tier F), Influenza (evidence tier F), Herpes simplex (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Meglumine acridone acetate?

Common side effects of Meglumine acridone acetate (≥ 1 in 100): Per manufacturer label: allergic reactions. See the Safety section for uncommon and serious reactions.

Is Meglumine acridone acetate safe during pregnancy?

Contraindicated in pregnancy.

Is Meglumine acridone acetate compatible with breastfeeding?

Contraindicated during breastfeeding.

Who should not take Meglumine acridone acetate?

Meglumine acridone acetate is contraindicated in: Hypersensitivity to any component; Decompensated liver cirrhosis; Pregnancy and breastfeeding; Age under 4 years. Full list in the Safety section.

a Cycloferon shot boosts the immune system

'boosting immunity' is a lay notion without clinical meaning. The immune system operates on pathogen-specific responses, not on a 'stronger-weaker' axis. Non-specific stimulation is either a null effect or a risk of autoimmune reactions.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Oseltamivir, Ritonavir, Tilorone, Umifenovir, Vitaglutam, Darunavir, Famciclovir, Valacyclovir