The Sodium Chlorite Case: Why Lack of Patent Is No Excuse to Avoid New Drug Approval

For decades, a common refrain in alternative medicine circles and even among frustrated clinicians has been: "We can't run trials on this substance because there's no patent protection." This claim has become the go-to excuse for why promising older drugs or unconventional therapies never make it through FDA approval, never enter formal clinical use, and remain on the fringes of medicine.

But this claim is simply not true.

The recent case of NP001, a formulation of sodium chlorite developed by Neuvivo for the treatment of ALS (amyotrophic lateral sclerosis), should put this myth to rest once and for all. Sodium chlorite is an old, inexpensive, industrial chemical compound, widely known and without any viable composition-of-matter patent protection. It would be hard to find a more basic, unpatentable molecule. Yet Neuvivo has managed to bring it to late-stage clinical development and in October 2024 submitted a New Drug Application (NDA) to the U.S. FDA.

If approved, NP001 will become the first disease-modifying therapy for ALS that works not by acting on neurons, but by restoring balance in the innate immune system. It would offer a new immunological mechanism of action, potentially preserving lung function and extending life for up to a year in a population where most drugs offer mere months of survival benefit.

And what did it take to reach this point?

• Not a new molecule.

• Not a blockbuster patent.

• Not massive pharmaceutical muscle.

Just a company willing to invest in rigorous science, biomarker-driven clinical design, and a clear regulatory strategy for an off-patent compound.

Lack of Patent = Lack of Effort

The argument that "no one will fund trials without a patent" rests on a flawed assumption: that the only way to protect market exclusivity is through composition patents. This has never been true. In the United States, the FDA grants data exclusivity periods for new chemical entities (NCEs) and new indications for old drugs:

• 5 years of exclusivity for NCEs.

• 3 years for new uses of existing drugs (e.g., new indications or delivery systems).

• 7 years for orphan drug status.

• 12 years for biologics.

In addition, developers can apply for Fast Track, Breakthrough Therapy, and Priority Review designations, accelerating time to market and increasing commercial value.

This means that even a molecule with no patent protection can enjoy 3 to 7 years (or more) of commercial exclusivity if approved. That’s more than enough to recoup investment and generate significant profit—especially if the drug addresses a high-burden disease.

Neuvivo's NP001 is a perfect case in point. Despite its lack of a defensible compound patent, Neuvivo can expect:

• FDA exclusivity for several years.

• Potential pricing in the range of $100,000/year or more.

• Monopoly control over ALS patients who need this specific formulation and delivery protocol.

Accessibility Doesn’t Equal Commercial Threat

Critics might argue: if patients can easily make sodium chlorite at home, won't that undermine the business model?

Not at all.

Patients may be able to buy or even make crude sodium chlorite, just like people can grow their own herbs. But clinics and hospitals cannot administer unapproved, unverified, or non-standardized compounds. Insurance will not cover it. Most patients will not risk self-dosing. And regulatory scrutiny ensures that only products with clinical-grade documentation will be adopted by the mainstream medical system.

Neuvivo’s success will not rely on hiding the chemical identity of NP001. It will depend on:

• The strength of its clinical data.

• The precision of its dosing and delivery method.

• Regulatory endorsement.

• Physician confidence.

In short, success comes not from secrecy, but from trust, validation, and reproducibility.

Why Most "Miracle Substances" Stay in the Shadows

Given this framework, we have to ask: if sodium chlorite can make it to the FDA, why haven’t all these other so-called miracle substances?

Substances like:

• Ivermectin for cancer

• Fenbendazole for brain tumors

• Chlorine dioxide for infection or cancer

• Bicarbonate for fungal control

• DMSO, MMS, and others

One important exception is chlorine dioxide, which—despite years of controversy and misinformation—is now entering formal clinical investigation for cancer treatment through precisely delivered intratumoral injection.

As the inventor of this approach, I have personally overseen preclinical studies, early compassionate-use applications, and multi-country implementation. Our work shows that when used via localized injection, chlorine dioxide operates as a potent, tumor-destroying oxidative therapy with minimal systemic toxicity.

This case underscores the central argument of this article: any compound—no matter how old or misunderstood—can become a legitimate therapy if backed by science, clinical data, and regulatory vision.

If even one of these compounds has the power claimed by its proponents—curing late-stage cancers, reversing chronic illness, regenerating tissue—then there would be no excuse not to run proper trials. The cost of early-phase clinical trials is relatively modest, especially for high-impact diseases.

The truth is this: the absence of clinical trials often reflects the absence of replicable, high-impact effects, not the absence of patents.

If a compound truly worked as described, there would be enormous financial incentive for someone—anyone—to invest in trials. The idea that no one wants to make billions from an unpatented cure doesn’t hold up under scrutiny.

But What About Suppression by Big Pharma?

Some argue that the reason these substances haven’t been clinically tested is because they’re being suppressed by pharmaceutical companies.

While this belief is widespread in alternative health circles, it doesn’t match how the regulatory or investment landscape actually works.

The FDA provides market exclusivity (3–7 years) for old drugs repurposed for new uses—even without a patent. Investors routinely fund trials for generic compounds if there’s strong preliminary data. Dozens of repurposed drugs have succeeded this way.

The real problem isn’t suppression. It’s the absence of infrastructure:

· No one leads trials.

· No standardized formulations.

· No dosing data.

· No toxicology.

· No regulatory filings.

I know this firsthand—because I have walked the path. As the inventor of intratumoral chlorine dioxide therapy, I have developed the formulation, overseen studies, and coordinated real-world treatments across countries.

It’s not Big Pharma blocking the door. It’s the lack of organizations willing to do the difficult, disciplined work of taking a controversial therapy and proving its worth with science.

Blaming suppression may feel righteous. But it’s no substitute for responsibility.

A New Standard for Judging Alternative Therapies

For patients exploring alternative treatments, this insight offers a valuable lens:

If a treatment remains in the shadows for years, decades even, without any attempt at clinical validation, then it's reasonable to question how real or reliable its effects actually are.

Yes, there are regulatory hurdles.
Yes, clinical trials are hard.
Yes, it takes commitment, strategy, and some capital.

But if Neuvivo can do it with sodium chlorite, then there is no excuse for any truly effective compound to remain forever outside the system.

This should become the new rule of thumb for patients evaluating alternative therapies:

• Is there a clear path to clinical validation?

• Has anyone attempted it?

• If not—why not?

Because the absence of patents is not a valid excuse. Not anymore.

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About the Author:

Xuewu Liu is the inventor of Intra-Tumoral Chlorine Dioxide Therapy, with over a decade of research and clinical experience in oxidative therapeutics for cancer and chronic disease. He has published extensively on chlorine dioxide's mechanisms, applications, and successful case studies worldwide. Learn more at cdsxcancer.com or follow his Substack at clo2xuewuliu.substack.com.