Acridone acetic acid manufacturers

About acridone acetic acid

Acridone acetic acid manufacturers are led by Polysan of St Petersburg, Russia, which sells the meglumine salt as Cycloferon. Acridone acetic acid (INN cridanimod) is a low-molecular-weight interferon inducer and immunomodulator. It was first synthesised in the USSR in the 1970s. Cycloferon is used in Russia and some CIS countries for viral infections. Pharmaceutical companies can source acridone acetic acid API and finished products through supply, out-licensing or technology transfer.

Acridone acetic acid key facts

Acridone acetic acid manufacturers and licensing history

Acridone acetic acid was first synthesised in the USSR in the 1970s. Polysan, founded in St Petersburg in 1992, developed Cycloferon, the meglumine salt. Cycloferon injection was registered by the Russian Ministry of Health in 1995, and Polysan received its production licence in 1996.

Cycloferon was added to Russia’s List of Vital and Essential Drugs in 2010. It is sold as 150 mg enteric-coated tablets, 12.5% injection and a topical liniment. The Ukrainian registration for the injection ended in March 2018.

Sodium cridanimod was licensed from Polysan and Pharmsynthez to Xenetic Biosciences for development in endometrial cancer. Xenetic’s Phase 2 study was terminated because of a change in development strategy, not for safety reasons.

Acridone acetic acid is photosensitive and poorly soluble in its free-acid form, so salt formation is key to formulation. Buyers should confirm GMP status, the salt form and stability data before choosing a supply partner.

Acridone acetic acid dosage forms and dossier types

Acridone acetic acid is marketed as meglumine acridone acetate in tablets, injection and liniment. Most licensing interest is in the oral tablets and the injection.

Acridone acetic acid regulatory and patent status

Cycloferon injection was registered in Russia in 1995, followed by tablets and liniment. It is on Russia’s List of Vital and Essential Drugs. Cycloferon is not approved in the US or EU, and it does not appear in international treatment guidelines for influenza or herpes. Malaysia’s health technology assessment agency noted that Cycloferon is not registered there.

Sodium cridanimod received FDA orphan drug designation for endometrial cancer, but its Phase 2 study was terminated. Check national patent registers for salt, formulation and use patents before filing.

Acridone acetic acid mechanism of action and therapeutic use

Acridone acetic acid induces the body’s own production of interferons, mainly type I (alpha and beta) and type II (gamma). It is also reported to activate macrophages and T lymphocytes. In Russia, Cycloferon is used for viral infections such as influenza, acute respiratory infections, herpes and viral hepatitis, in adults and children over 4 years old. Evidence for these uses comes mainly from Russian studies.

Acridone acetic acid licensing and sourcing

Acridone acetic acid suppliers and licensing partners typically offer finished-product supply, dossier out-licensing or technology transfer. Buyers usually compare GMP status (EAEU GMP, WHO GMP), dossier format, salt form and territory availability. Current offers and supplier contacts are listed among the acridone acetic acid manufacturers on Pipelinepharma.

Frequently asked questions about acridone acetic acid

Who are the main acridone acetic acid manufacturers?
Polysan of St Petersburg is the originator and main manufacturer, selling the meglumine salt as Cycloferon. Xenetic Biosciences licensed sodium cridanimod for cancer development but has stopped its Phase 2 study.

What is the difference between acridone acetic acid, cridanimod and Cycloferon?
Acridone acetic acid is the chemical name, and cridanimod is its INN. Cycloferon is Polysan’s brand of the meglumine salt, meglumine acridone acetate. Sodium cridanimod is the sodium salt used in US clinical trials.

Which countries produce acridone acetic acid?
Russia is the main producer of acridone acetic acid finished products, through Polysan in St Petersburg. Buyers should confirm the salt form and the GMP status of the manufacturing site.

Is acridone acetic acid approved in the EU or US?
No. Acridone acetic acid is not approved in the EU or US. Cycloferon is registered in Russia and some CIS countries.

What forms and strengths of acridone acetic acid are available?
Cycloferon is available as 150 mg enteric-coated tablets, a 12.5% injection in 2 ml ampoules, and a topical liniment.