Dazukibart
An investigational treatment for Dermatomyositis.
The same compound appears under different names depending on the context. Here is how to identify Dazukibart wherever you encounter it, plus the key facts at a glance.
- Generic name
- Dazukibart
- Development code
- PF-06823859
- Drug class
- Monoclonal antibody (anti-IFN-beta)
- Manufacturer
- Pfizer
- How it's taken
- Dazukibart is given as an intravenous infusion over 60 minutes, every 4 weeks.
An investigational antibody that specifically targets interferon beta, one of the key immune signals driving skin and muscle inflammation in dermatomyositis. It is in a Phase 3 trial.
We'll email you when the FDA acts on Dazukibart and when new trials for Dermatomyositis open. Unsubscribe anytime.
How Dazukibart works
Dazukibart is a monoclonal antibody that blocks interferon-beta (IFN-beta), a signaling protein that drives inflammation in dermatomyositis. This protein is abnormally high in people with dermatomyositis, making it a very specific target. By neutralizing IFN-beta, the drug helps reduce both skin rash and muscle weakness.
Mechanism: Monoclonal antibody specifically blocking interferon beta
Side effects and safety
Treatment-related adverse events occurred in about 80% of both treatment and placebo groups. Serious adverse events occurred in 4-11% depending on dose. Most side effects were manageable, though the higher dose (600 mg) had slightly more safety concerns.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Dazukibart
Dazukibart is given as an intravenous infusion over 60 minutes, every 4 weeks. In Phase 2 trials, patients received either 150 mg or 600 mg doses. The drug is administered at a medical facility and is currently still in clinical trials.
Clinical trial results
In a Phase 2 trial of 75 adults with dermatomyositis at 25 hospital and outpatient sites in 5 countries, dazukibart 600 mg given by IV every 4 weeks reduced skin disease activity at week 12 compared with placebo, the trial's main goal. Results were published in The Lancet in January 2025. Pfizer then started a Phase 3 trial (NCT05895786) in about 318 people with dermatomyositis or polymyositis, which is recruiting.
Main registered trial: NCT05895786 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Development history
Dazukibart (PF-06823859) was developed by Pfizer as a humanized monoclonal antibody targeting interferon-beta. Phase 2 results were published in The Lancet in January 2025, and a Phase 3 trial began in 2023. Pfizer lists US and EU orphan designations, FDA Fast Track and EU PRIME for the program.
Explore Dermatomyositis trials
Other Dermatomyositis treatments
Common questions about Dazukibart
▸What is Dazukibart?
An investigational antibody that specifically targets interferon beta, one of the key immune signals driving skin and muscle inflammation in dermatomyositis. It is in a Phase 3 trial.
▸How does Dazukibart work?
Dazukibart is a monoclonal antibody that blocks interferon-beta (IFN-beta), a signaling protein that drives inflammation in dermatomyositis. This protein is abnormally high in people with dermatomyositis, making it a very specific target. By neutralizing IFN-beta, the drug helps reduce both skin rash and muscle weakness.
▸What are the side effects of Dazukibart?
Treatment-related adverse events occurred in about 80% of both treatment and placebo groups. Serious adverse events occurred in 4-11% depending on dose. Most side effects were manageable, though the higher dose (600 mg) had slightly more safety concerns.
▸How is Dazukibart taken?
Dazukibart is given as an intravenous infusion over 60 minutes, every 4 weeks. In Phase 2 trials, patients received either 150 mg or 600 mg doses. The drug is administered at a medical facility and is currently still in clinical trials.
▸Is Dazukibart FDA approved?
Dazukibart is currently in phase 3 clinical trials for Dermatomyositis. It has not yet received FDA approval.
▸What does dazukibart target?
Dazukibart is being studied for dermatomyositis by Pfizer. It targets specific immune pathways involved in the inflammatory muscle and skin damage that characterizes dermatomyositis.
▸What is the current development status?
Dazukibart is in Phase 3. Pfizer's Phase 3 trial (NCT05895786) is recruiting people with dermatomyositis or polymyositis, and an open-label extension study is also running.
▸How is dazukibart administered?
Dazukibart is given as an IV infusion every 4 weeks at a medical facility, in both the Phase 2 and Phase 3 trials.
▸What unmet need does dazukibart address?
Dermatomyositis has limited approved targeted therapies. Most current treatments involve broad immunosuppression with significant side effects. Dazukibart represents a more targeted approach being investigated for this condition.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- PubMed · 2025-01-11. Efficacy, safety, and target engagement of dazukibart in dermatomyositis: a phase 2 trial. https://pubmed.ncbi.nlm.nih.gov/39798982/
- ClinicalTrials.gov. Phase 3 study of PF-06823859 in active idiopathic inflammatory myopathies. https://clinicaltrials.gov/study/NCT05895786