One night after eating a particularly spicy Indian dish, Mir Imran had an epiphany.
As he watched an Alka-Seltzer tablet fizz in his glass of water, the medical solutions inventor saw a potential way to build a long sought-after oral biologic.
That was over a decade ago. In 2012, Imran’s idea become the basis for his company Rani Therapeutics, a clinical stage biotech developing a swallowable, auto-injecting pill that navigates to the gastrointestinal tract where there “are no sharp pain receptors” and releases medication into the intestinal wall using a microneedle. Now led by Imran’s son Talat Imran, the company is testing what it calls the RaniPill for the delivery of medications in a variety of indication areas, including in phase 1 trials for its pulmonary neuroendocrine tumor candidate RT-101 and osteoporosis treatment RT-102.
“This is really an ideal solution for patients with chronic diseases, because chronic diseases require chronic therapies, and injectable therapies are very hard to tolerate long term,” Imran said.
The race is on to bring to market the first-ever pill-packaged biologic, as most such medications are currently delivered through shots and infusion. The oral biologics and biosimilars market is expected to grow to $9.44 billion in 2026, $5 billion over its 2021 market level. And major players, including Novo Nordisk, are jumping in.
As part of a multi-year partnership, the Danish pharma has an exclusive license to MIT’s Soma robotic pill which entered a phase 1 trial in March and could expect results as early as this month. Smaller companies like Intract Pharma, who’s pioneering an oral delivery for Janssen’s Crohn’s disease medication Remicade, are also entering the market.
The competition doesn’t intimidate Imran, though.
“I think it's a good thing that people are trying to knock us off — it shows that it's not just us with a crazy idea,” he said. “I don't want to say bring them on, but I think it's validation that what we're doing is important.”
Although it’s still early, recent results from the company’s single-ascending dose study of RT-102 showed promise. During the trial, no RaniPill related adverse impacts were recorded and the capsule, which in this candidate contains a proprietary formulation of osteoanabolic teriparatide, showed higher bioavailability than its injected counterpart.
“What we've already demonstrated in a single dose (pharmacokinetic) phase 1 study is that we're getting absorption that rivals the subcutaneous injection,” Imran said of the results, noting that the company is now conducting a repeat dosing study of RT-102 for further validation.
“Our goal is to be the first-line biologics company."
CEO, Rani Therapeutics
“If this was phase 1 data of a new chemical entity, there’s not a lot you can extrapolate from that. There’s still a 90% chance of failure. But if you look ahead in this case, if we can consistently deliver the drug, we have a lot of confidence that we’re going to be able to affect the clinical endpoint,” he said.
If successful, Imran hopes the tech, which is about the size of a fish oil supplement, could help make biologic medications more accessible earlier in the care continuum for serious chronic diseases.
“If you look at treatment regimens, patients typically start on small molecule oral therapies, and they only move on to the injectables when they're so sick that they require them,” he said.
This is especially true in the treatment of osteoporosis, where patients are typically only prescribed osteoanabolic medications that stimulate bone growth after the condition has progressed to moderate or severe. For the 200 million women worldwide who suffer from the condition, the loss of bone mass and lack of treatment can lead even minor falls to cause life-altering breaks and fractures.
“We looked at that and said, OK, this is a place where if you brought an oral therapy into this category that was as good or better (than the current standard), clinicians and endocrinologists could potentially start women on these therapies earlier,” Imran said.
Additionally, the RaniPill could address widespread medication adherence issues with the disease. Researchers estimate that between 50% and 70% of patients discontinue osteoporosis medications within the first year due to factors including adverse effects and the laborious nature of self-injecting medication.
“A lot of things can happen at the site of injection,” Arvinder Dhalla, vice president of clinical development at Rani said, noting the potential for infections and irritation if patients do not administer the shot correctly.
As for the cost, Imran said he estimates the RaniPill “should be on par” with current injectors “depending on the injection frequency.”
Right now, Rani is using medications that have been on the market for years or is opting to collaborate with pharmas who have drugs that are a good fit for the delivery system.
So far, the company has completed a research partnership with Takeda and is still fulfilling a five-plus year collaboration with Novartis. It’s also working with an undisclosed partner in the creation of an ingestible biosimilar of AbbVie’s Humira and is in conversations with potential partners for two potential diabetes candidates.
“We're very careful that we have to live with these programs even after the announcement. And so we want to pick things that are going to be real market opportunities and significant for the patients who are treated with those drugs,” Imran said of Rani’s approach to partnerships.
“Diabetes is obviously something that everyone thinks about when you think about injectable biologics. Those markets are complicated … so it's not something that we could undertake on our own,” Imran said.
In the future, however, the company is hoping to partner with more companies on newer drug formulations, either still in formulation or not off patent, and “go from there to maybe new chemical entities as well,” including monoclonal antibody and immunology candidates, according to Dhalla.
“Our goal is to be the first-line biologics company,” Imran said. “I think over the next few years, hopefully, we'll bring enough of these candidates into the clinic to make that happen.”