Eight hundred capsules have been swallowed by animals. Swine. Dogs. Macaques. Not one by a person. In December, that count stops being zero.
On 4 November 2026, Biora Therapeutics said Australia's Human Research Ethics Committee cleared the first-in-human study of BioJet, an ingestible capsule built to deliver biologic drugs. The device is the size of a 00 capsule. Inside sits a liquid jet that fires the drug through the wall of the small intestine.
The milestone is procedural, not clinical. An ethics committee approved a protocol. Nobody has shown that the capsule puts a therapeutic antibody into human blood at a useful level. That is the test ahead.
The wall that stopped oral biologics
Proteins and antibodies do not survive the stomach. They also cross the gut lining badly. For two decades the workaround has been the same: put them in a syringe.
The drug industry has tried to fix this at the molecule level. Permeation enhancers, enteric coatings, protease inhibitors, nanoparticle carriers. Each works in some settings. None has produced a general oral option for monoclonal antibodies. A 2026 review in Frontiers in Drug Delivery describes the shift from formulation tricks toward active delivery devices.
Device approaches stop fighting the barrier and drive through it. The capsule carries the drug intact, then injects it into tissue where absorption already works. Rani Therapeutics has taken this route with its RaniPill. A phase 1 study of an ustekinumab biosimilar delivered by that device reported 81% relative bioavailability against subcutaneous injection. Different device, different mechanism, same bet.
BioJet narrows the bet in one respect. It does not reformulate the drug. Biora says the capsule accepts existing liquid formulations and delivers them through a high-velocity jet into the small-intestine wall. No new molecule. No new excipient. A new route in.
CHRONICLE: Oral biologic delivery, Biora branch
────────────────────────────
2023 · 🐖 51.3% bioavailability in 9 pigs (earlier device)
SEP 2026 · 📄 Trial plans disclosed; NCT07849153 registered
NOV 2026 · ✅ Australian HREC approval granted (4 Nov)
◉ NOW · ⏳ Dosing planned for December 2026
🔥 NEXT · 📊 Topline PK data expected early 2027
Chronology: Biora Therapeutics releases; ClinicalTrials.gov NCT07849153
What the capsule does
Inside BioJet, a small reservoir holds the drug. Once the capsule reaches the small intestine, the device triggers a jet that pushes the liquid into the intestinal wall at high velocity. The drug enters tissue instead of the open gut lumen.
That distinction carries the engineering. A jet has to penetrate deep enough to reach vascular tissue, shallow enough to avoid perforation, and consistent enough to produce predictable plasma levels. The capsule is single-use and designed to handle proteins, peptides and nucleic acids without changing their formulation.
Biora reports more than 800 capsules dosed across swine, canines and non-human primates. The platform has been tested with monoclonal antibodies, peptides and oligonucleotides. The patent estate includes more than 20 granted patents, with coverage in the United States, Europe, Japan and China.
For a drugmaker, the commercial appeal is obvious. An oral version of an injectable biologic can extend a brand's life, improve adherence and open markets where cold-chain injection is hard. The same logic has kept oral-biologic programmes funded through years of failed attempts.
The December protocol, line by line
The study is registered as NCT07849153, an early-feasibility Phase 1 trial in about 30 healthy adults in Australia. It is randomised, open-label and single-dose. Participants receive one of three treatments, and the primary readouts are safety, tolerability and pharmacokinetics.
| Arm | Route | Dose |
|---|---|---|
| BioJet | Oral capsule | 30 mg |
| Comparator 1 | Subcutaneous injection | 20 mg |
| Comparator 2 | Subcutaneous injection | 40 mg |
Source: ClinicalTrials.gov NCT07849153, posted 30 September 2026
One detail is easy to miss. The trial does not use Humira. It uses Hadlima, an adalimumab biosimilar, at 30 mg through the capsule against 20 mg and 40 mg injected under the skin. Adalimumab was chosen because its behaviour after injection is unusually well documented. That gives the device a reference curve instead of a research question.
The trial's estimated primary completion is 15 January 2027, with full completion expected in February. Biora says dosing begins in December 2026 and topline data arrive in early 2027. The principal investigator is James Connell of CMAX Clinical Research. A data monitoring committee is listed in the registration.
Bioavailability is the number that matters. The study will measure Cmax, Tmax and area under the curve for the oral arm, then compare those values with the injected arms. A device that delivers drug safely but at 5% of the injected exposure will not carry a commercial programme. A device that lands in a workable range, with variability close to an injection, changes the conversation.
What 51.3% in pigs does not prove
The strongest preclinical number Biora has published is a 2023 result: 51.3% average bioavailability for a 56 mg dose in a nine-animal porcine study, with variability similar to subcutaneous injection. That figure came from an earlier version of the device, in a small group of animals.
Animal data is a gate, not a guarantee. Pig intestine is not human intestine. A healthy volunteer is not a patient with Crohn's disease or rheumatoid arthritis, whose gut may be inflamed or scarred. And the 2023 study tested Biora's own adalimumab variant, not the Hadlima biosimilar now in the protocol.
The company is explicit that the device is investigational and not approved for commercial use. No human safety, tolerability or pharmacokinetic data exist yet. The trial will start with single doses in healthy people, which limits the safety picture to short-term events.
There are device-specific risks to watch. Poor jet placement could produce low or erratic absorption. Repeated dosing, if it comes later, will test intestinal tolerability and immune response to the biologic. The capsule also has to pass through the gut safely in every participant.
What would count as success
A clean result would look modest on paper: acceptable safety, no serious gastrointestinal events, and oral exposure that supports further testing. The trial is not powered to prove efficacy. It is powered to answer whether the route works at all.
The comparison that matters is not BioJet versus a placebo. It is oral exposure versus subcutaneous exposure in the same study, with the same drug. If the oral arm reaches a meaningful fraction of the injected curve, Biora has a platform argument to take to partners. If it does not, the company has another animal dataset and a longer timeline.
Oral bioavailability relative to the 20 mg and 40 mg injected arms
Variability between participants — a wide spread kills the commercial case
Gastrointestinal safety events in the first 30 days
The wider wager
Oral biologics have consumed a lot of capital for a small number of wins. The field has heard this pitch before, and the caution is earned. Still, the mechanical route has one advantage over formulation science: it does not ask the molecule to become something it is not.
Biora's December study will not settle whether pills can replace injections for the world's antibody drugs. It will settle something narrower. It will show whether a jet fired inside the gut can put an antibody into the bloodstream on purpose, and on schedule. That answer is worth more than the capsule itself.
For now, the trial has an approval, a protocol and a date. The rest is biology.