CellCentric has developed a novel cancer drug that is now in extensive clinical trials in the UK, mainland Europe and the US. It is first in its class, targeting twin key cancer regulatory proteins, p300 and CBP. Up to this point, the drug has been known by its research code name, CCS1477. The company has recently received confirmation of its allocation of an International Nonproprietary Name, or generic name (INN), inobrodib. This blog explains the process by which drugs gain their names.
Generic names for drugs are actually decided by the World Health Organisation, based on submissions from drug development companies. They have an international panel of drug name experts that work with national nomenclature committees. They ensure consistency of INN allocations, and aim to avoid any potential confusion between drugs.
Inobrodib (pronounced “in-oh - broh-dib”) is the name agreed for CellCentric’s CCS1477. The -brodib suffix proposed and agreed, represents the new class of drug; p300/CBP bromodomain inhibitors. Any subsequent follower drugs with a similar mechanism of action will have to bear the same -brodib stem.
CellCentric worked with Kaleio Inc, to develop an overall appropriate INN name to propose to the WHO, both the prefix and suffix components. We began by sharing information describing CCS1477’s mechanism of action, its chemical structure, along with key details from the Investigators Brochure (IB). The Kaleio Team then proposed around 60 potential name candidates, permutations of novel first half and second half components, which adhered to tight INN rules and guidelines, and trademark and regulatory requirements. The CellCentric team then reviewed each name to refine the overall direction, including the key concepts, tonality and construction style, and suggesting additional contenders. It was an interesting exercise to note how different people respond to different potential names, particularly when it came to the important class-defining novel suffix.
Developing an INN for the first time is a fun and creative process, and something most drug discoverers rarely get to experience. CellCentric chose to work with Kaleio Inc, who have a depth of experience and expertise in the naming process, to help guide us.
The top 30-40 candidates were then screened using Kaleio proprietary software to uncover potential trademark conflicts. Proposed names get rejected if they sound or look too alike to existing drugs, which could potentially lead to confusion when referring to or prescribing a new agent. The screening also included linguistic screening to uncover any translation or transliteration issues across more than a dozen different languages. The final list was then whittled down to the top 6 by the CellCentric team, and the documentation submitted to the INN Expert Group at the WHO.
There was then a three month wait to hear which, if any, of the proposed names had been selected by the WHO committee. The INN Group can select any one of the six nominations, or a new construct generated by combining different portions from two or more of the submitted candidates, or even a totally new name generated by the committee. Fortunately the name generation and screening work we had carried out did meet its purpose, and we were delighted when the WHO selected our preferred name of inobrodib, including the novel drug class stem, -brodib.
Inobrodib was published by WHO as a proposed INN in List 125 in July 2021, but could not be used straightaway. There is a required four month period for external comment and objection. This has now passed, with the name unchallenged, and inobrodib will be published as the recommended INN in the upcoming rINN List 87.
Note, the INN or generic name is the one representing the active substance and is uniformly known globally. It is different from the brand name for any drug. For instance, the drug enzalutamide (INN) is marketed in the US, UK and elsewhere, as Xtandi (brand name). The marketing names can differ by country and geography, but the INN cannot.
CCS1477 is now inobrodib. We are really pleased to see its continued progress to benefit people with cancer. It is a name that will become more familiar.