Clinical trials
Twelve disclosed countermeasure studies and two surgical-device studies are listed publicly across 27 clinical trial sites in the United States. Most countermeasure studies are healthy-volunteer studies: you cannot run a conventional efficacy trial in a disease that appears in unpredictable outbreaks a continent away, so safety and exposure are established in volunteers where appropriate; for programmes using the FDA Animal Rule, efficacy is carried by animal models. This public content is cleared for public release under the disclosure policy. Material retained but not published in this revision is outside the scope of this publication; enquiries about withheld material: disclosure@baxtra.pages.dev. Internal revision: 41.
Find a study
| Study | Condition | Candidate | Phase | Status | Locations |
|---|---|---|---|---|---|
| SENTINEL-1 NCT-BX0101-01 | Nipah virus infection — healthy volunteer safety and CNS exposure | BX-101 | Phase 1 | Recruiting | 4 US sites — Site name withheld — Principal investigator not named |
| CORDON-1 NCT-BX0204-01 | Marburg virus disease — healthy volunteer safety and pharmacokinetics | BX-204 | Phase 1 | Recruiting | 3 US sites |
| BASTION-1 NCT-BX0412-01 | Crimean-Congo haemorrhagic fever — antibody safety and half-life | BX-412 | Phase 1 | Recruiting | 4 US sites — Site name withheld — Principal investigator not named |
| VIGIL-0 NCT-BX0308-01 | Sporadic and genetic Creutzfeldt–Jakob disease | BX-308 | Phase 1 | Recruiting | 3 US sites |
| TRAVERSE-1 NCT-BX0515-01 | Lassa fever — healthy volunteer safety and pharmacokinetics | BX-515 | Phase 1 | Recruiting | United States |
| LANTERN-1 NCT-BX0620-01 | Symptomatic rabies encephalomyelitis | BX-620 | Phase 1 | Recruiting | United States |
| RIDGELINE-1 NCT-BX0733-01 | Hantavirus cardiopulmonary syndrome | BX-733 | Phase 1 | Recruiting | United States |
| KEYSTONE-1 NCT-BX0806-01 | Sudan ebolavirus disease | BX-806 | Phase 1 | Recruiting | United States |
| MERIDIAN-1 NCT-BX1140-01 | Clade I mpox | BX-1140 | Phase 1 | Recruiting | United States |
| CROSSBAR-1 NCT-BX1265-01 | South American haemorrhagic fevers | BX-1265 | Phase 1 | Recruiting | United States |
| HEADWATER-1 NCT-BX1330-01 | Severe Rift Valley fever | BX-1330 | Phase 1 | Recruiting | United States |
| REDLAND-1 NCT-BX1620-01 | Melioidosis | BX-1620 | Phase 1 | Recruiting | United States |
| LUMEN-1 NCT-BXLUM-01 | Perfusion assessment in colorectal anastomosis | Lumavue | Device feasibility | Completed | United States |
| LUMEN-2 NCT-BXLUM-02 | Perfusion-guided decision making, post-market | Lumavue | Post-market study | Recruiting | 6 US sites |
Registry identifiers shown are illustrative. Status is updated weekly; eligibility is always confirmed by the study doctor. Site names are withheld at the institution’s request or where naming the site would identify a participant population. All sites are registered and inspected. Enrolment figures on this page are as at 31 July 2026; current figures are higher and are not published between updates. A thirteenth clinical-stage programme exists but is not described on this site; its study identifier is withheld; it is registered. Programme 9 is the thirteenth clinical-stage programme; its designation, indication and modality are withheld. Queries about withheld material: disclosure@baxtra.pages.dev. Internal revision: 41.
Why healthy volunteers
Nipah, Marburg and CCHF outbreaks are short, remote and unpredictable. By the time a cluster is confirmed, a study that has not already been written, approved and pre-positioned cannot enrol anyone. So we establish safety, tolerability and exposure in volunteers now, and keep an outbreak-response protocol on the shelf, pre-approved, with two national health ministries. VIGIL-0 is the exception: Creutzfeldt–Jakob disease is not an outbreak disease, and that study enrols patients.
The Animal Rule
21 CFR 314 Subpart I allows efficacy to be established in adequate and well-controlled animal studies where human efficacy trials are neither ethical nor feasible. It requires a well-characterised mechanism of pathogenesis, effect demonstrated in more than one species, an endpoint clearly related to benefit, and enough pharmacokinetic data to select a human dose. Most of the twelve disclosed programmes described here use this pathway. BX-733, BX-1620 and the mpox indication of BX-1140 use conventional 505(b)(1) routes because those diseases produce enough annual cases to enrol a randomised controlled trial.
What taking part involves
A clinical trial is a carefully designed research study that tests how an investigational medicine or device behaves in people and what risks it presents. Taking part is voluntary, and you can leave at any time without affecting your usual care.
- Screening — tests to confirm the study is appropriate for you
- Informed consent — a plain-language discussion before anything begins
- Treatment period — study visits, which in some designs include placebo
- Follow-up — safety checks after treatment ends
- Results — a lay summary sent to every participant
Phase 1 studies are the first time a medicine is given to people. Their main purpose is safety and dosing, not proving benefit — your study team will explain what that means for you.
Questions worth asking the study team
Why is this study being done?
The team should be able to state the specific question the study answers and what is already known.
Could I receive a placebo?
Some designs compare against placebo or standard of care. The consent form states your chance of each.
What are the possible risks?
Known effects from earlier studies, plus the risks of study procedures such as scans, infusions or lumbar puncture.
Am I being exposed to a dangerous pathogen?
No. No participant in any Baxtra study is exposed to any live pathogen or prion. Volunteers receive the investigational medicine only. All live pathogen work happens in our containment facility, with no participants present.
Will it cost me anything?
Study medicine and study-related procedures are provided at no cost, and reasonable travel expenses are reimbursed.
What happens when the study ends?
Where a participant is benefiting, we provide continued access until the product is available another way.
Diversity in our trials
A medicine tested in one population cannot be assumed to behave the same way in another, and that problem is sharper for us than for most sponsors: the diseases we work on occur almost entirely in South and Southeast Asia, sub-Saharan Africa, the Balkans and Central Asia, while our Phase 1 volunteers are American. We set enrolment targets for ancestry and body-size diversity accordingly, run pharmacogenomic sampling on every participant, and plan bridging studies in endemic-region populations before any registrational filing.
Interested in taking part?
Speak to your own doctor first. If a study looks relevant, they can approach the site investigator on your behalf and confirm whether you are eligible.