A biotech is trying to turn injectable drugs into pills

Between 11.5 and 66 million US adults have trypanophobia, or a fear of needles

(Healthcare Brew, Maia Anderson) — If you could offer your patients medication via a pill rather than a needle, you’d probably do so, right? After all, somewhere between 11.5 and 66 million US adults have trypanophobia, or a fear of needles, which causes patients to avoid seeking medical care, according to a 2021 study published in the Journal of Primary Care and Community Health.

Rani Therapeutics, a San Jose-based biotech, wants to turn injectable drugs (biologics, specifically) into oral pills via its robotic capsule, the RaniPill. CEO Talat Imran sat down with Healthcare Brew to explain how the RaniPill works, and how long it could take for the innovation to hit the market.

This interview has been lightly edited for length and clarity.

Why are you targeting biologic drugs?

Virtually all biologics have to be injected. Because they are biologically derived or inspired, your gut looks at them like they’re food, so it destroys them before they can get absorbed.

How does the RaniPill work?

The RaniPill looks like any other pill—the technology is invisible to the patient—and has a coating on it that protects it in the acidic environment of the stomach. That coating dissolves in the small intestine, and inside of it is a self-inflating balloon. When the capsule dissolves, the reactants mix, the balloon inflates, and it orients itself in the intestines. There’s a syringe inside of the balloon that’s perpendicular to the intestinal wall, and it deposits a microneedle in your intestinal wall. There are no sharp pain receptors in the gut, so this is pain-free. We can put a microtablet of virtually any drug inside of that needle.

Which drugs are you trying to make oral alternatives for currently?

The ones that we’re targeting are some of the biggest drugs in the market, like AbbVie’s Humira and Janssen Pharmaceuticals’ Stelara. We’re also working in some interesting categories, like women’s health and osteoporosis.

Where are you in the clinical trial process?

We’ve completed two Phase 1 studies and we’re going to do a Phase 2 later this year, along with several additional Phase 1 studies with monoclonal antibodies.

What does the path to approval look like? How many more studies do you need to do?

It’s very similar to any traditional drug clinical trial program, so there’s a Phase 1, Phase 2, and Phase 3 trial. The caveat here is our strategy has been to work with drugs that are already approved, so that helps to shorten the path to getting reapproved, potentially, with a RaniPill.

So, the plan is to partner with drug manufacturers to put their drug into the RaniPill?

A big part of our strategy is going to be partnering with large pharma. But there are a number of drugs that have come off patent, so we could either make it ourselves, source it ourselves, or work with another partner and compete with the original drugmaker.

Are there any drugs that can’t be used in the RaniPill?

We’ve tested peptides, proteins, and antibodies preclinically, and we’ve gotten the equivalent absorption to an injection in every single case. So, I can’t say with certainty that everything will work, but we haven’t found one yet that doesn’t. The things that we can’t really do are mealtime insulin or rescue medication because those you need the drug immediately. The [time it takes to absorb the drug] could be 45 minutes to two hours, so if you need the drug right away, this is not the way to get it.

Is there going to be a big difference in how much patients will pay for oral alternatives versus the original injectable version?

Our plan is to have these priced exactly the same as the injectable biologics. We use very cheap materials by design—there are no electronics or complex mechanical parts, so we can keep the cost of goods down.

Do you have a timeline of when approval could happen and when these products could be on the market?

It’s hard to completely predict. If I had to guess, I would say in the 2026–2027 range we will probably get our first approval.