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Emergency anthrax drug trial set to launch if outbreak strikes

NCT ID NCT03569553

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a medicine called AIGIV for people who have breathed in anthrax germs during a large-scale emergency. The goal is to see if the drug helps more people survive and to check for side effects. The study will only start if a major anthrax event happens, and it will include up to 100 patients.

Why investors are watching

Emergent BioSolutions is testing AIGIV, an antibody treatment for inhalational anthrax, in a field study that would only run during a major anthrax exposure event. For a small-cap company with a focus on biodefense, this trial tests whether its product works in a real-world emergency, which could affect its standing with government buyers. The outcome matters because anthrax treatments are a niche market where success depends on regulatory and public health confidence.

If it works: A positive result could strengthen Emergent's position as a supplier of anthrax countermeasures, potentially leading to more government contracts or stockpile orders. It would also validate AIGIV as a useful tool in a public health crisis, which could support future revenue from emergency preparedness programs.

If it fails: The trial may never enroll participants, since it only activates during a major anthrax event, so the company might not get the data it needs. If the study does run and AIGIV shows poor safety or no clear benefit, it could damage the product's credibility and hurt Emergent's biodefense business.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Inhalational anthrax patients who have received AIGIV.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario. * Treatment with AIGIV. * Informed consent/assent (as applicable). Exclusion Criteria: * There are no exclusion criteria for subjects enrolling in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.