AT-1501, a drug invented at the ALS Therapy Development Institute (ALS TDI) and being developed by Eledon Pharmaceuticals, has a new name: tegoprubart. AT-1501 is the first ALS treatment ever to be invented by a nonprofit and reach human ALS clinical trials. This renaming is an important step in the drug’s development, coming soon after Eledon’s announcement of the full enrollment of its phase 2 trial.
One Drug, Three Names
A drug can be known by many different names along the journey from discovery to testing to being put on the market. Drug candidates like AT-1501 are usually referred to by letters and numbers in their earlier stages of development, a name known as a compound code. The letters generally indicate the company that developed the treatment – all compounds being investigated by one company will generally begin with the same letters. The numbers are given to distinguish each compound during preclinical testing. As many companies will test hundreds or thousands of different compounds during the various phases of drug discovery, it is much more practical to refer to them by number than by each individual’s chemical name.
Many investigational treatments retain their compound code well into clinical trials. However, as a drug candidate advances through clinical testing it must eventually be assigned a generic name, also known as an international nonproprietary name (INN). This is the name the drug will be known by anywhere in the world it is sold, even if it is available under different brand names or as a generic. Some common examples generic INN names include ibuprofen, often sold under the brand name Advil in the US, and acetaminophen, also sold under the brand name Tylenol.
A drug’s brand name is selected by the sponsor after it is approved, and is used to market the drug to patients and physicians. These names are less tightly regulated than generic names, but are still subject to some rules and approval by regulatory bodies.
Where Generic Names Come From
Tegoprubart, the name newly assigned to AT-1501, is it’s INN or generic name. In the US, generic names are initially suggested by the drug’s trial sponsor. The sponsor submits a number of possible names an organization known as the United States Adopted Name (USAN) Council. The council will review these for approval and then select one as the drugs official name. The name must then be reviewed by the World Health Organization INN Programme for international use.
These names must follow certain rules, and are subject to approval by both national and international regulators. The most tightly regulated element of a generic drug name is the suffix, or the letters at the end of the name. There are specific suffixes assigned to different types of drugs. Some common examples include -vir for antiviral drugs (such as the covid-19 antiviral remdesivir) or -cillin for certain types of antibiotics (such as penicillin). In tegoprubart’s case, -bart indicates that it is a particular kind of monoclonal antibody.
The first part of the name, besides the suffix, is less descriptive and more creative. Companies try to select names that are distinct from other drugs in the same category on the market to avoid confusion. The name cannot include anything that could be considered marketing for the original manufacturer, because it will be used when the drug is sold as a generic. It also needs to avoid terminology that is related to its initial intended medical use, in case later on it is discovered the drug is useful for treating other conditions.
With its newly assigned generic name, the next step in tegoprubart’s development will be the completion of its phase 2 trial. According to its sponsor, Eledon pharmaceuticals, top-line results are expected in the second quarter of 2022.
What To Do Next
