Alpha-glycerylphosphorylcholine manufacturers

About alpha-glycerylphosphorylcholine

Alpha-glycerylphosphorylcholine (alpha-GPC) manufacturers include the originator Italfarmaco (Gliatilin) and more than 100 Korean companies, led by Chong Kun Dang and Daewoong. Alpha-GPC, also called choline alfoscerate, is a choline compound used to support cognitive function. It is a prescription medicine in Italy, Korea and some other countries, and a dietary supplement in the US. Pharmaceutical companies can source alpha-GPC capsules, injection and API through out-licensing, supply or technology transfer.

Alpha-glycerylphosphorylcholine key facts

Alpha-glycerylphosphorylcholine manufacturers and licensing history

Italfarmaco developed alpha-GPC as Gliatilin. In 2000, Italfarmaco licensed it to Daewoong for Korea, and the licence later moved to Chong Kun Dang. Daewoong now sells its own product, Gliatamin.

Korea became the largest market, with prescriptions of KRW 352.5 billion in 2019. In 2020, Korean regulators began re-evaluating the drug. The health ministry cut reimbursement for patients without dementia, and the food and drug ministry ordered clinical trials to confirm efficacy. Of 278 approved products, 134 have been withdrawn, but the remaining market continued to grow.

In Japan, most choline alfoscerate products were withdrawn after re-evaluation. In the US, alpha-GPC is sold as a dietary supplement. Buyers should confirm GMP status, a DMF and the local regulatory status before choosing a dossier partner.

Alpha-glycerylphosphorylcholine dosage forms and dossier types

Alpha-GPC is approved as soft capsules, oral solution and injection. Generic manufacturers most often develop 400 mg soft capsules.

Alpha-glycerylphosphorylcholine regulatory and patent status

Alpha-GPC is off-patent and approved as a prescription medicine in Italy, Korea and some other countries. In Korea, a 2020 re-evaluation led to reduced reimbursement for patients without dementia and an order for new clinical trials. Many products have been withdrawn, and court challenges have delayed some reimbursement cuts. Check the current Korean status before filing.

Alpha-glycerylphosphorylcholine mechanism of action and therapeutic use

Alpha-GPC releases choline in the body, which the brain uses to make acetylcholine, a neurotransmitter involved in memory and learning. It is used for cognitive decline in older adults and, in some countries, after stroke. Approved indications differ between countries.

Alpha-glycerylphosphorylcholine licensing and sourcing

Alpha-GPC suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status, dossier format, clinical data and territory availability. Current offers and supplier contacts are listed among the alpha-glycerylphosphorylcholine manufacturers on Pipelinepharma.

Frequently asked questions about alpha-glycerylphosphorylcholine

Who are the main alpha-GPC manufacturers? Italfarmaco is the originator of Gliatilin. In Korea, Chong Kun Dang sells Gliatilin and Daewoong sells Gliatamin, among more than 100 companies with alpha-GPC products.

What is the difference between alpha-GPC and choline alfoscerate? They are the same substance. Choline alfoscerate is the INN, and alpha-GPC is the common chemical name.

Is alpha-GPC approved in the US? No. In the US, alpha-GPC is sold as a dietary supplement, not as an approved drug.

What happened to alpha-GPC in Korea? In 2020, Korean regulators cut reimbursement for patients without dementia and ordered new clinical trials. Of 278 products, 134 have been withdrawn, but prescriptions continue to grow.

What forms and strengths of alpha-GPC are available? Alpha-GPC is available as 400 mg soft capsules, oral solution and 1,000 mg injection.