Navenibart for hereditary angioedema

Last updated July 2, 2025, by Andrea Lobo, PhD
Fact-checked by Joana Carvalho, PhD

What is navenibart for hereditary angioedema?

Navenibart, formerly known as STAR-0215, is an experimental injectable therapy that is being developed as a prophylactic treatment to prevent swelling attacks in people with hereditary angioedema (HAE).

It is an antibody-based therapy that’s designed to block the activity of kallikrein, an enzyme that is overactive in HAE and increases the production and release of bradykinin — a signaling molecule that causes blood vessels to widen and leak fluid into tissues, causing swelling. By inhibiting kallikrein, navenibart is expected to reduce bradykinin levels, thus preventing HAE swelling attacks.

The therapy, administered via subcutaneous, or under-the-skin, injections, is being developed by Astria Therapeutics and is currently being tested in a Phase 3 clinical trial.

Navenibart has received orphan drug status for HAE in both the U.S. and Europe. These designations aim to speed the development and regulatory review of treatments for rare diseases.

Therapy snapshot

How will navenibart be administered?

In clinical trials involving HAE patients, navenibart has been administered via subcutaneous injections, generally once every three or six months, at doses of 300 to 600 mg, following several dosing regimens.

Navenibart in clinical trials

Navenibart has been tested in a series of clinical trials, including a Phase 1b/2 study and its extension study, involving adults with HAE type 1 or 2. Available data from these studies showed that navenibart was safe and able to reduce the rate of monthly swelling attacks.

• ALPHA-STAR (NCT05695248), where navenibart was found to be safe and well tolerated, and able to reduce the rate of monthly swelling attacks by 90% to 95% after six months, when given once or twice, at doses of 300 mg to 600 mg.
• ALPHA-SOLAR extension study (NCT06007677), where navenibart continued to safely reduce the rate of monthly swelling attacks in patients who had completed ALPHA-STAR. Initial results from the extension study showed the therapy had reduced the monthly rate of HAE attacks by a mean of 92% over the course of approximately 10 months, when given at a dose of 300 mg every three months or 600 mg every six months.

Navenibart’s safety and efficacy against a placebo are currently being assessed in a Phase 3 clinical trial called ALPHA-ORBIT (NCT06842823), which is enrolling up to 145 adolescents and adults, ages 12 and older, with HAE type 1 or 2. Top-line data are expected in 2027.

Common side effects of navenibart

The most common treatment-emergent side effects reported in clinical trials testing navenibart in HAE patients were:

• injection site reactions, including redness, swelling, itching, and rash
• cold-like symptoms (nasopharyngitis)
• sinus inflammation (sinusitis)
• urinary tract infections
• skin laceration
• nasal congestion
• headache.

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