Most professionals in the oncology and immunology clinical trial spaces have heard of the wonder drug, Rituximab, an anti-CD20 antibody with a vast array of potential therapeutic uses ranging from arthritis to myeloma.

First approved by the Food and Drug Administration in 1997, Rituximab has spent a very long time waiting for its breakout. After a long period under patent, Rituximab is now available for clinical trial experimentation by anyone and everyone worldwide, leading to an influx of new studies in a huge number of disease areas and geographical locales.

Let’s investigate the nature of the new clinical trials spurred by Rituximab’s generic status using Trial Finder to see exactly how useful researchers think that it could be.


Setting Up the Analysis

First, we will set up a filter to only examine studies involving Rituximab or Rituxan, its brand name.

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Next, we will filter for active or soon to be active studies; there is already an abundance of completed studies on Rituximab which characterize its basic clinical effects and more.

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Finding Rituximab Trials

Using the above filter, TrialFinder tells us there are 46 Rituximab trials.

46 is a good number of new trials, considering that each is examining the same molecule in a slightly different use case. Of these trials, most are in oncology, although a notable minority are in immunology thanks to Rituximab’s anti-CD20 mechanism of action is via B-cells.

Interestingly, there are a few studies which think that Rituximab has promise in fighting infectious diseases, curbing inflammation—likely in the context of arthritis—and even in neurology. 

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How far along are these studies, and how soon can we expect to see therapies featuring Rituximab for these new indications becoming available to patients in need?

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Just as we would expect with a drug whose patent has recently expired, there are quite a few extant studies at the early Phase 1, Phase 1, and Phase 1 / Phase 2 transition points. Just as unsurprisingly, there are quite a few Rituximab trials at Phase 3—efficacy testing—which should be relatively easy to reach outcomes because of Rituximab’s previously established safety profile and human tolerability.

Most of the initial work was performed by the companies that brought Rituximab to the market in the first place, notably, there was a body of literature publicly available beforehand which may have helped guide early efforts.[1] This begs the question of how Rituximab is being further developed if industry sponsors are unlikely to have interest in conducting clinical trials on a generic drug.



Who are the players currently pushing new indications of Rituximab in clinical trials

As it turns out, while industry sponsors aren’t as common as individual privately funded nonprofit organizations, companies are still interested in testing Rituximab further, perhaps to see if it is possible to patent it in a radically different formulation or indication that is outside the scope of the original patent portfolio.

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While only time will tell what other cures and treatments Rituximab can offer, the clinical trials investigating its use are off to a running start and show promise for improving patient outcomes.


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