Welcome back, everyone. We have an update from Jaguar Health. Trades on the NASDAQ under the symbol JAGX. It's a commercial-stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Happy to welcome Founder, CEO, President, and Director Lisa Conte. Welcome back, Lisa. We're excited for your update today.
Oh, thanks so much. Good timing for the update. And I really appreciate the description you gave as the entry. And of course, that's what we do. All our drug discoveries for prescription products from plants that have been used traditionally in tropical areas. We do do it for humans and animals. Humans is the primary source of our business and our focus of our efforts. But today, we made a very interesting announcement about Canalevia-CA1, which is our FDA-approved drug for chemotherapy-induced diarrhea in dogs. It too is plant-based, organic, sustainably harvested, fair trade. And it's an FDA-approved drug by the Center for Veterinary Medicine, CVM, division of the FDA. So what we announced today is the FDA approval of the renewal of the conditional approval for chemotherapy-induced diarrhea. So what does that mean, the conditional approval? Chemotherapy-induced diarrhea in dogs is a complete unmet medical need.
So that term gets thrown around a lot. There's nothing that is labeled that is tested as a prescription pharmaceutical for chemotherapy-induced diarrhea in dogs. And because it's a specialized market in the veterinary world called MUMS, which is like an orphan indication in the human world, the FDA gives you approval to sell for that indication based on safety, which of course we have with this product in humans as well as animals. This is the same active ingredient as our human FDA-approved product for chronic diarrhea in people living with HIV/AIDS, and also based on a reasonable expectation of efficacy. And the reasonable expectation of efficacy came from a study that we did in general acute diarrhea in dogs.
So based on that, you have a conditional approval, and then you need to do a confirmatory study in the indication, the conditional indication, chemotherapy-induced diarrhea in dogs within five years to get the full approval for that indication. And within those five years, each year, the FDA, the Center for Veterinary Medicine, monitors what's going on and reapproves the product for the next year up to five years. So that's what got announced today. What got announced about a month or so ago is we also got a $250,000 grant awarded to us based on the trial design that we have submitted to get the full approval for CID. So that's very exciting as well. Now, we call this our emotional support program because it's not a large part of what we do in this company, but it's very important. Everybody loves their animals.
It was a little bit of financial support as well. I think our stock responded with a 20%-25% increase today, which is terrific, and it's important. Our mission is to not only bring this product to full approval for chemotherapy-induced diarrhea in dogs, but to full approval for all acute diarrhea and all diarrhea, acute and chronic, in dogs, and what we had also announced about a month ago, or maybe about a week ago, is we have filed in Europe with EMA, the equivalent of the FDA in Europe, for advice to seek approval for acute diarrhea, all acute diarrhea in dogs, based on that study that I mentioned that was utilized for reasonable expectation of efficacy here in the United States for the conditional approval, so there is a demonstrated pathway in Europe for veterinary prescription product indications to be approved off of one pivotal trial.
In the U.S., we will need to do two, and so in the U.S., the Canalevia-CA1 program is the subject of business development conversations to partner with these companies where animal health is their main focus of business to expand our indication from chemotherapy-induced diarrhea to all diarrhea in doggies and in Europe to seek advice to potentially get that approval based on the data that we have in hand right now, so when we're talking about chemotherapy-induced diarrhea, it is just remarkable. I mean, sometimes it's been referred to first-world dogs living in third-world conditions because their nose is in the ground, in the environment, in the bushes, whatever it is that they're pulling up, so there's a lot of diarrhea, but in particular, there's a lot of cancer.
And so it's 50%, estimated at 50% of the dogs over the age of 10 at some point will experience cancer, about 6 million new cases diagnosed each year in the United States. And that's likely underreported for any number of reasons that cancer may not be fully diagnosed in an animal. Pet owners are typically paying out of their pocket and showing the strong, strong commitment to the comfort of the dog, in fact, the comfort of the whole family when a loved one is so ill and to have, and you can't talk to them, you can't explain to them, for example, that they may have GI distress, that they may have diarrhea, that you really want to address the supportive care needs of the treatment that the patient is going through.
But when we expand to general diarrhea, now we're talking about of the 90 million dogs in the United States, about 15% at some point present with acute diarrhea. That means present to the vet. So of course, there's a lot more that's going on in the household as well. So this becomes a very meaningful blockbuster indication within the veterinary world for the good of the patient, for the good of the caregivers, the family, and also for the financial opportunity for all the stakeholders in Jaguar as well as our investors. There is an interesting visual of the mechanism of action, which is actually the same, whether it's a dog or a human. These are the slices of the gut. And the way crofelemer works is highly conserved across all mammals.
So all the way on the left here, you see a slide of the gut and the chloride ion channels that get disrupted. In the middle, what happens is chloride ions come into the lumen of the gut. Those are those little green dots. Water comes in based on osmosis, and that's the diarrhea that's going out. What crofelemer does is it normalizes that ion flow, which normalizes the water flow, specifically mitigates the dehydration and the water loss. What is used now is often antibiotics. For example, metronidazole is used for treating diarrhea in dogs. It hasn't even been approved in dogs. It hasn't even been tested in dogs. And there's a lot of, there's a whole movement, and particularly in Europe, to not be utilizing antibiotics for all the reasons of resistance that we see in humans and the environment as a whole.
So it's a really, really important and powerful market for us to go into to expand from chemotherapy-induced diarrhea to general acute diarrhea into doggies. And I just want to end with, this is one of the major catalysts that we have coming up in the business development area to bring on partnerships to address the need in patients and to do so in a way that brings in non-dilutive dollars and additional resources to the company, both in terms of partnership expertise as well as those financial resources in a non-dilutive way. So that's our animal update for today.
Lisa, thank you so much. Yeah. So what sort of advice are you seeking from the EMA, and what could the implications of that be?
So with the EMA, as I mentioned, we're seeking advice. Can we file off of that one trial that we already have that shows statistical significance? And that would be approval in the 37 countries in the EU area. Right now, they don't have a conditional approval pathway. So no dog in the EU right now can even get the product for chemotherapy-induced diarrhea. So it would be a way to get it to those 37 countries and to get it all dogs with diarrhea, which will sort of leapfrog the availability that we have in the United States, which is going to require a second trial in the United States.
What exactly is a conditional approval?
The conditional approval is very interesting in animals. Conditional approval is very limited, not only in the on-label, like the education, the promotion that we can provide has to be on-label, as with any approval from the FDA. But it also has a reverse requirement. Veterinarians cannot prescribe off-label for dogs. So a veterinarian, interestingly, could prescribe Mytesi off-label from a human indication for a dog, but they can't prescribe Canalevia-CA1 conditionally approved for CID for any other diarrhea. So it's very important, A, that we get the full approval, and then we expand the approval as well.
Perfect, and any closing remarks for our viewers today, Lisa?
It's an important year of catalysts. I keep saying that anybody who pays attention to our company, it's happening, happening, happening based on the clinical data that we generated and the regulatory clarity that we generated on the human and animal side throughout 2025, so 2026 and early on in 2026 is going to be a big moment of catalyst for us.
Wonderful. Well, thank you for this update. We look forward to seeing you in the new year. Thanks again, Lisa.
Thanks a lot. Appreciate it.
All right, everyone. We'll be right back.