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Hemophilia A Prophylaxis Treatments Compared

Name: Hemophilia A Prophylaxis Treatments Compared
Creator: Jason Hunter
Published: 2026-10-01

4 FDA-approved drugs and 1 in development, side by side from the current prescribing labels. Newest label Jun 2026. Checked October 1, 2026.

Factor VIII mimeticHemlibra

TFPI blockersAlhemo · Hympavzi

Antithrombin silencerQfitlia

Four non-factor drugs are FDA-approved to prevent bleeds in hemophilia A, all given under the skin at home. Hemlibra, approved in 2017, is injected weekly, every 2 weeks or every 4 weeks. Hympavzi is once a week, Alhemo is once a day, and Qfitlia can be as few as 6 injections a year. Alhemo, Hympavzi and Qfitlia are also approved for hemophilia B. In their trials, treated bleeds per year fell by 71% to 97% compared with on-demand treatment or no prophylaxis. Qfitlia carries a boxed warning for blood clots and gallbladder disease and requires blood tests to set the dose. A fifth drug, denecimig, is under FDA review after its Phase 3 trial.

Side by side

4 approved hemophilia A treatments at a glance

How each drug is given, how often, who it is approved for and when it was first approved, from the current FDA label.

Hemophilia A treatments compared: route, schedule, approved use and approval date
Drug	How it is given	How often	Approved for	First approved
Alhemo concizumab-mtci Novo Nordisk	Under-the-skin injection with a prefilled pen, once a day	1 mg/kg loading dose on day 1, then 0.2 mg/kg once daily; dose adjusted to 0.15 or 0.25 mg/kg after a blood level check at week 4	Hemophilia A, with or without factor VIII inhibitors, age 12 and older, to prevent bleeds	December 20, 2024
Hympavzi marstacimab-hncq Pfizer	Under-the-skin injection with a prefilled pen or syringe, once a week	300 mg loading dose, then 150 mg once weekly (age 12 and up); 150 mg then 75 mg weekly for ages 6 to 11. Can be raised to 300 mg weekly if bleeds continue	Hemophilia A, with or without factor VIII inhibitors, age 6 and older, to prevent bleeds	October 11, 2024
Hemlibra emicizumab-kxwh Genentech (Roche)	Under-the-skin injection weekly, every 2 weeks, or every 4 weeks	3 mg/kg once weekly for 4 weeks, then 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks	Hemophilia A, with or without factor VIII inhibitors, all ages from newborn, to prevent bleeds	November 16, 2017
Qfitlia fitusiran Sanofi (Genzyme); discovered by Alnylam	Under-the-skin injection with a prefilled pen, as few as 6 times a year	50 mg once every 2 months to start; dose and timing adjusted (10 to 50 mg, every 1 or 2 months) to keep antithrombin activity at 15% to 35%	Hemophilia A, with or without factor VIII inhibitors, age 12 and older, to prevent bleeds	March 28, 2025

The calendar

A year on each hemophilia A treatment

Every dose in a year, drawn to the label schedule, so the difference between a daily pill and a twice-yearly infusion is the picture.

Alhemo

Injection, at home

365 doses a year

Hympavzi

Injection, at home

52 doses a year

Hemlibra

Injection, at home

3 mg/kg once weekly for 4 weeks, then 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/k... (no fixed yearly count)

Qfitlia

Injection, at home

6 doses a year

Counts follow the label schedule for a full year on the maintenance dose. Drugs given in cycles or adjusted to blood tests have no fixed count, so their schedule is written out instead.

The evidence

What the pivotal hemophilia A trials showed

The primary result from the trial each FDA approval rests on, as reported on the label.

Before you compare

How to read the hemophilia A trial results

1
These are prophylaxis drugs that prevent bleeds
A bleed that happens anyway is still treated with factor VIII or a bypassing agent, at reduced doses on Qfitlia and with strict limits on aPCC for Hemlibra.
2
The bleeding rates come from different comparisons
Alhemo and Hemlibra were tested against randomized groups on no prophylaxis. Hympavzi compared each person against their own earlier period on factor. Qfitlia's approved dose was tested in an extension study and compared with on-demand control arms from the earlier trials. Hympavzi and Qfitlia labels pool hemophilia A and B.
3
Monitoring differs
Alhemo needs a drug-level blood test at week 4, Qfitlia needs antithrombin tests to set the dose and monthly liver tests, and Hemlibra and Hympavzi need no routine drug-level tests.

Hemophilia A pivotal trial results by drug
Drug	Pivotal trial	Primary result
Alhemo concizumab-mtci Novo Nordisk	explorer8 (no inhibitors), 156 people, 90 with hemophilia A; explorer7 (inhibitors), 133 people, 80 with hemophilia A Trial record or paper	Hemophilia A without inhibitors: 2.7 treated bleeds per year on Alhemo vs 19.3 with no prophylaxis (86% lower). With inhibitors (A and B pooled): 1.7 vs 11.8 (86% lower)
Hympavzi marstacimab-hncq Pfizer	BASIS, 116 people without inhibitors (91 with hemophilia A) and 48 with inhibitors; BASIS KIDS, 57 children Trial record or paper	No inhibitors (A and B pooled): 3.2 treated bleeds per year on Hympavzi vs 39.9 on on-demand factor (92% lower); 5.1 vs 7.9 for people switching from factor prophylaxis. With inhibitors: 1.4 vs 19.8 on on-demand bypassing agents (93% lower)
Hemlibra emicizumab-kxwh Genentech (Roche)	HAVEN 3 (no inhibitors), 152 people age 12 and up; HAVEN 1 (inhibitors), 109 people; HAVEN 2 children; HAVEN 4 every-4-week dosing Trial record or paper	No inhibitors (HAVEN 3): 1.5 treated bleeds per year on weekly Hemlibra and 1.3 on every-2-week Hemlibra vs 38.2 with no prophylaxis (96% to 97% lower). With inhibitors (HAVEN 1): 2.9 vs 23.3 (87% lower)
Qfitlia fitusiran Sanofi (Genzyme); discovered by Alnylam	ATLAS-A/B (no inhibitors), 120 people, 93 with hemophilia A; ATLAS-INH (inhibitors), 57 people, 45 with hemophilia A; results use the ATLAS-OLE extension Trial record or paper	No inhibitors (A and B pooled): 9.0 treated bleeds per year on Qfitlia vs 31.4 on on-demand factor (71% lower). With inhibitors: 5.1 vs 19.1 on on-demand bypassing agents (73% lower)

Safety

Hemophilia A treatment side effects and warnings

Hemlibra and Qfitlia carry a boxed warning, the FDA's strongest. The rest list their main precautions.

Hemophilia A treatments: most common side effects and key warnings from the FDA labels
Drug	Most common side effects	Key warning
Alhemo concizumab-mtci Novo Nordisk	injection site reactions 7% to 18%, headache 7% and hives (urticaria) 6%	No boxed warning. Blood clots (1.9% in trials), allergic reactions, and raised clotting lab markers (D-dimer).
Hympavzi marstacimab-hncq Pfizer	injection site reactions 12%, headache 7% and fever 6%	No boxed warning. Blood clots (0.8% in the extension study), allergic reactions, possible harm to an unborn baby.
Hemlibra emicizumab-kxwh Genentech (Roche)	injection site reactions 22%, headache 15% and joint pain 15%	Boxed warning Boxed warning: thrombotic microangiopathy and blood clots when combined with high doses of the bypassing agent aPCC. Also interferes with standard clotting lab tests.
Qfitlia fitusiran Sanofi (Genzyme); discovered by Alnylam	viral infections 29%, common cold symptoms (nasopharyngitis) 26% and bacterial infections 11%	Boxed warning Boxed warning: blood clots and gallbladder disease. Also liver injury; monthly liver tests for at least 6 months, antithrombin blood tests to set the dose.

Not yet approved

Hemophilia A treatments in Phase 3 or under FDA review

Investigational drugs with a Phase 3 trial, shown separately because their results are not from a label. Status as of the date in each row.

Hemophilia A drugs in development
Drug	Status	How it works and is given	Pivotal trial	Result so far	What is next
denecimig (Mim8); EU brand name Frehemgo Novo Nordisk	Under FDA reviewas of October 1, 2026	Factor VIIIa mimetic bispecific antibody (same class as Hemlibra) that bridges factor IXa and factor XUnder the skin with a prefilled pen, once a month, every 2 weeks, or weekly	FRONTIER2 (NCT05053139), Phase 3, 254 people age 12 and up in the main analysis (281 enrolled per ClinicalTrials.gov)Primary endpoint: Number of treated bleeds (annualized bleeding rate) over 26 weeks vs prior factor prophylaxis or on-demand treatment ClinicalTrials.gov	Met primary endpoint: monthly denecimig cut treated bleeds about 99% vs on-demand treatment and about 43% vs prior factor prophylaxis; weekly denecimig cut them about 96% and 54%. 64% to 95% of people on denecimig had zero treated bleeds (Novo Nordisk release, 2026-04-29; NEJM doi:10.1056/NEJMoa2517384)	No date announced Novo Nordisk press release, April 29, 2026

No longer available: Roctavian (valoctocogene roxaparvovec-rvox), approved June 30, 2023, withdrawn. NO LONGER AVAILABLE.

Cost

Help paying for hemophilia A treatment

Drugmaker copay and free-drug programs, plus charity funds for the condition, checked every week.

Questions

Hemophilia A treatment questions people ask

What is the least frequent hemophilia A prophylaxis?

Qfitlia (fitusiran), which starts at 50 mg under the skin once every 2 months and is adjusted by antithrombin blood levels to as few as 6 injections a year. Hemlibra can be given every 4 weeks, Hympavzi is weekly and Alhemo is daily.

Is Hemlibra better than Hympavzi?

No trial has compared them. In HAVEN 3, people without inhibitors on Hemlibra had 1.5 treated bleeds a year on weekly dosing against 38.2 with no prophylaxis. In BASIS, people on Hympavzi had 3.2 treated bleeds a year against 39.9 during their earlier on-demand period. The designs differ, so the numbers are not a head-to-head result. Both are weekly or less often, self-injected, and need no routine drug-level monitoring.

Which hemophilia A drugs work with inhibitors?

All 4 approved non-factor drugs cover people with factor VIII inhibitors on their current labels: Hemlibra since its first approval, Alhemo for inhibitors first, and Hympavzi and Qfitlia under their current labels. Alhemo is approved from age 12, Hympavzi from age 6 under its June 2026 label, Hemlibra for all ages and Qfitlia from age 12.

Is denecimig approved for hemophilia A?

Not as of October 2026. Novo Nordisk filed it with the FDA in September 2025 after the FRONTIER2 trial, where monthly denecimig cut treated bleeds by about 99% against on-demand treatment and 43% against prior factor prophylaxis. Novo has not disclosed a decision date. It received a positive opinion from the EU's medicines committee in September 2026 under the name Frehemgo.

What happened to Roctavian?

Roctavian, the one-time gene therapy for severe hemophilia A approved in June 2023, was withdrawn from the market by BioMarin in February 2026. It is listed on this page for the record but is no longer available.

Go deeper

More on Hemophilia A at Trial Friend

Sources

Where every number on this page comes from

Approved-drug facts are from the current FDA prescribing information on DailyMed, with the label's effective date. Investigational-drug facts are from ClinicalTrials.gov and the sources named in each row.

Alhemo (concizumab-mtci) prescribing information, Novo Nordisk, label dated Jul 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
Hympavzi (marstacimab-hncq) prescribing information, Pfizer, label dated Jun 2026. DailyMed. Pivotal trial: ClinicalTrials.gov
Hemlibra (emicizumab-kxwh) prescribing information, Genentech (Roche), label dated Jul 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
Qfitlia (fitusiran) prescribing information, Sanofi (Genzyme); discovered by Alnylam, label dated Sep 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
denecimig (Mim8); EU brand name Frehemgo, Novo Nordisk: ClinicalTrials.gov record; Novo Nordisk press release, April 29, 2026. Checked October 1, 2026.

This page compares what the FDA labels and pivotal trials report. It is not medical advice, and no trial on this page compared these drugs with each other. Written and checked by Jason Hunter; the method is on the editorial standards page.