Anti-TFPI monoclonal antibody

Alhemo (concizumab)

An approved treatment for Hemophilia A and Hemophilia B.

FDA Approved (2024)by Novo Nordisk
Preclinical
Phase 1
Phase 2
Phase 3
Approved
2024
Drug facts

The same compound appears under different names depending on the context. Here is how to identify Concizumab wherever you encounter it, plus the key facts at a glance.

Generic name
Concizumab
Brand name
Alhemo
Development code
NN7415
Drug class
Anti-TFPI monoclonal antibody
Manufacturer
Novo Nordisk
How it's taken
Given as a once-daily subcutaneous injection.

A subcutaneous antibody treatment that blocks TFPI, a natural anticoagulant, to restore clotting balance in hemophilia A and B patients with or without inhibitors. Given daily by self-injection.

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Where Concizumab fits

Subcutaneous prophylactic therapy for hemophilia A or B, with or without inhibitors. Provides a non-factor approach to bleed prevention through TFPI inhibition.

How Concizumab works

TFPI (tissue factor pathway inhibitor) is a protein that naturally dials down clotting. In hemophilia, where clotting factors are already deficient, TFPI makes the problem worse. Concizumab binds to TFPI and blocks it, removing an extra brake on the clotting system. This restores enough clotting activity to prevent bleeds, regardless of whether the patient has factor inhibitors.

Mechanism: Monoclonal antibody that inhibits tissue factor pathway inhibitor (TFPI) to restore clotting balance

Side effects and safety

What patients report

Injection site reactions are the most common side effect. Thromboembolic events (blood clots) are a known risk and require monitoring. Allergic (hypersensitivity) reactions, including rare anaphylaxis, can occur. Headache and hives are among the most common side effects. Patients should be monitored for signs of excessive clotting. The label also warns that Alhemo raises the results of 2 clotting blood tests (D-dimer and prothrombin fragment 1.2), so these tests may not be reliable for checking whether you have a blood clot.

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 Concizumab

Given as a once-daily subcutaneous injection. Patients self-administer at home using a pre-filled pen. Treatment starts with a 1-time loading dose, then a daily dose. About 4 weeks after starting, a blood test measures the level of concizumab in your blood, and the daily dose is adjusted based on that result. Approved for patients aged 12 and older.

Availability and cost

No generic available

Only available as the brand-name product.

Why it costs what it costs

Anti-TFPI monoclonal antibody administered as daily subcutaneous self-injection. Novel mechanism for hemophilia prophylaxis in an area dominated by factor replacement therapies.

Help paying for Alhemo

Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.

Your insurance
From the drugmaker
Alhemo (Concizumab)
NovoCare (Rare Bleeding Disorders)
  • Copay help

    Commercially insured patients may pay as little as $0 per fill for Alhemo, up to $15,000 savings per calendar year; offer valid 48 months from enrollment.

    For: private insurance · source
  • Bridge or quick-start supply

    JumpStart and Interim programs may provide a limited free supply if commercial insurance is delayed or has a gap.

    For: private insurance · source
  • Free medicine program

    Patients with no insurance may qualify for free medicine through the Novo Nordisk Patient Assistance Program.

    For: no insurance · source
  • Other support

    Patient Trial Program may provide a free, limited supply for patients new to treatment; provider completes the NovoCare enrollment form.

    The official page does not say who qualifies. Ask the program. · source
  • Insurance and case manager help

    NovoCare checks insurance coverage, shares prior authorization information, explains appeals, and coordinates with a specialty pharmacy.

    The official page does not say who qualifies. Ask the program. · source

Good to know: Savings offer excludes Medicare, Medicaid, Medigap, VA, DOD, TRICARE and other government programs. NovoCare notes services may vary by product; call 1-844-668-6732 to confirm eligibility.

Checked on the drugmaker's official pages on September 24, 2026. Programs change; confirm with the program before you rely on it.
Charity funds
  • From a charity · Hemophilia Federation of America
    Helping Hands Program fund
    Open

    Pays for: Emergency living expenses ($250 prepaid card, once per year; referral through HTC or member organization; does not cover medical bills, copays or premiums), up to $250 per year.

    The foundation says: “The Helping Hands program is now open on a limited basis for 2026. Due to funding constraints, a maximum of 20 requests will be approved…”
  • From a charity · TotalAssist (formerly PAN Foundation)
    Hemophilia fund
    Open

    Pays for: Out-of-pocket costs for approved medications, up to $12,500 per year. Requires health insurance (any kind).

  • From a charity · The Assistance Fund
    Hemophilia fund
    Waitlist

    Pays for: Copays, coinsurance, deductibles and other health-related expenses.

    The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Status as each foundation showed it on October 5, 2026.

More ways to get help paying for treatment →

Clinical trial results

The explorer program (explorer7 and explorer8 trials) demonstrated significant reduction in annualized bleeding rates compared to no prophylaxis in hemophilia A and B patients with and without inhibitors.

Development history

Developed by Novo Nordisk. Approved by FDA in December 2024 for bleeding prophylaxis in people 12 and older with hemophilia A or B with inhibitors. In July 2025, the FDA expanded the approval to people 12 and older with hemophilia A or B without inhibitors. Represents a novel mechanism targeting TFPI rather than replacing missing clotting factors.

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Common questions about Concizumab

▸What is Concizumab (Alhemo)?

A subcutaneous antibody treatment that blocks TFPI, a natural anticoagulant, to restore clotting balance in hemophilia A and B patients with or without inhibitors. Given daily by self-injection.

▸How does Concizumab work?

TFPI (tissue factor pathway inhibitor) is a protein that naturally dials down clotting. In hemophilia, where clotting factors are already deficient, TFPI makes the problem worse. Concizumab binds to TFPI and blocks it, removing an extra brake on the clotting system. This restores enough clotting activity to prevent bleeds, regardless of whether the patient has factor inhibitors.

▸What are the side effects of Concizumab?

Injection site reactions are the most common side effect. Thromboembolic events (blood clots) are a known risk and require monitoring. Allergic (hypersensitivity) reactions, including rare anaphylaxis, can occur. Headache and hives are among the most common side effects. Patients should be monitored for signs of excessive clotting. The label also warns that Alhemo raises the results of 2 clotting blood tests (D-dimer and prothrombin fragment 1.2), so these tests may not be reliable for checking whether you have a blood clot.

▸How is Concizumab taken?

Given as a once-daily subcutaneous injection. Patients self-administer at home using a pre-filled pen. Treatment starts with a 1-time loading dose, then a daily dose. About 4 weeks after starting, a blood test measures the level of concizumab in your blood, and the daily dose is adjusted based on that result. Approved for patients aged 12 and older.

▸Is Concizumab FDA approved?

Yes, Concizumab (Alhemo) is FDA approved (2024) for the treatment of Hemophilia A and Hemophilia B.

▸How does concizumab differ from emicizumab for hemophilia prophylaxis?

Concizumab targets tissue factor pathway inhibitor (TFPI) and works for both hemophilia A and B, while emicizumab mimics Factor VIII and only treats hemophilia A. Concizumab requires daily injections versus emicizumab's weekly-to-monthly schedule, but covers both hemophilia types with a single drug.

▸Can concizumab be used in patients with Factor VIII or IX inhibitors?

Yes. Concizumab is approved for hemophilia A and B patients both with and without inhibitors. Since it works by blocking TFPI rather than replacing missing clotting factors, inhibitor status does not affect its mechanism of action.

▸What monitoring is needed while taking concizumab?

Patients require monitoring for thromboembolic events (blood clots), which are a known risk. A blood test of concizumab levels is done about 4 weeks after starting to set the long-term daily dose, and may be repeated at later visits. Regular follow-up for signs of excessive clotting is recommended.

▸Is concizumab approved for children?

Concizumab (Alhemo) is approved for patients aged 12 and older. Studies in younger children are ongoing. Pediatric patients should discuss age-appropriate prophylaxis options with their hematologist.

▸How is concizumab administered at home?

Concizumab is self-administered as a once-daily subcutaneous injection using a pre-filled pen. Patients or caregivers receive training on proper injection technique before starting home administration.

▸What was studied in the explorer clinical trial program?

The explorer program included the explorer7 and explorer8 trials, which demonstrated significant reduction in annualized bleeding rates compared to no prophylaxis. explorer7 (patients with inhibitors) supported FDA approval in December 2024, and explorer8 (patients without inhibitors) supported the expanded approval in July 2025.

▸Can concizumab be combined with factor replacement therapy?

Concurrent use of concizumab with factor replacement requires careful management due to the increased risk of thromboembolic events. If breakthrough bleeding occurs and factor products are needed, the lowest effective dose should be used under physician guidance.

This page is for informational purposes only and does not constitute medical advice. Drug information is sourced from public databases and peer-reviewed literature and may not reflect the most recent updates. Always discuss treatment options with your healthcare provider. Last reviewed: October 2026.

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