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Kisunla vs Leqembi: how two US-approved medicines for Alzheimer's disease compare
A side-by-side guide for families in the Gulf, built from the US FDA labels, Gulf drug registers and official sources.
Reviewed by the Reserve Meds clinical operations team on 18 October 2026. Facts on this page come from the current US prescribing information for each medicine.
Kisunla vs Leqembi: the short answer
Kisunla and Leqembi are both US FDA-approved to treat Alzheimer's disease, started at the mild cognitive impairment or mild dementia stage. They are given on different schedules and no trial has compared them head to head. Your specialist decides which, if either, fits. Reserve Meds is a digital health company. We do not diagnose or prescribe.
- Condition: Alzheimer's disease.
- Main difference: Kisunla is an infusion every four weeks, and its label says to consider stopping once amyloid plaques fall to minimal levels on PET imaging.
- Head-to-head evidence: none in either US label.
- Price: Quote on request.
Kisunla and Leqembi side by side
The table summarizes each current US label. Labels are long; your specialist and hospital pharmacy work from the full text.
| Feature | Kisunla | Leqembi |
|---|---|---|
| Generic name | donanemab-azbt[2] | lecanemab-irmb[3] |
| Type of medicine | monoclonal antibody directed against amyloid beta[2] | monoclonal antibody directed against amyloid beta[3] |
| US-approved for | Alzheimer's disease. Treatment should be started in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was started in the clinical trials.[2] | Alzheimer's disease. Treatment should be started in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was started in clinical trials.[3] |
| First US approval (Drugs@FDA) | 2 July 2024 (first US approval). The current label does not mark this use as an accelerated approval.[2, 4] | 6 January 2023 (first US approval). The current label does not mark this use as an accelerated approval.[3, 5] |
| How it is given | Intravenous infusion over about 30 minutes every four weeks: 350 mg, then 700 mg, then 1,050 mg, then 1,400 mg from the fourth infusion. The label says to consider stopping once amyloid plaques fall to minimal levels on amyloid PET imaging.[2] | Two forms. An intravenous infusion of 10 mg/kg over about one hour every two weeks, or a 500 mg injection under the skin once a week with the LEQEMBI IQLIK autoinjector. After 18 months, treatment can continue at the starting dose or move to a maintenance dose: 10 mg/kg every four weeks by infusion, or 360 mg weekly by autoinjector.[3] |
| Where and what to expect | Amyloid pathology must be confirmed before starting, and ApoE ε4 testing should be done first. A recent brain MRI is needed before the first infusion, and MRIs are done before the 2nd, 3rd, 4th and 7th infusions to check for ARIA.[2] | Amyloid pathology must be confirmed before starting, and ApoE ε4 testing should be done first. A recent brain MRI is needed before starting, and MRIs are done after 1, 2, 3 and 6 months. After guiding at least 2 injections, the healthcare provider may decide that the patient or a caregiver can use the autoinjector.[3] |
| Boxed warning | Yes. Amyloid related imaging abnormalities (ARIA): brain swelling (ARIA-E) or small bleeds and iron deposits (ARIA-H). ARIA is usually without symptoms but can be serious or fatal, and the risk is higher in ApoE ε4 homozygotes.[2] | Yes. Amyloid related imaging abnormalities (ARIA): brain swelling (ARIA-E) or small bleeds and iron deposits (ARIA-H). ARIA is usually without symptoms but can be serious or fatal, and the risk is higher in ApoE ε4 homozygotes.[3] |
About Alzheimer's disease and these two medicines
Alzheimer's disease is the most common form of dementia among older people. It begins slowly and first involves the parts of the brain that control thought, memory and language, and its symptoms get worse over time.[1]
Kisunla and Leqembi are both antibodies directed against amyloid beta. Both labels say treatment should start at the mild cognitive impairment or mild dementia stage, the population in which treatment was started in the trials, and both require confirmation of amyloid pathology before starting.[2, 3]
The main difference
Kisunla is an infusion every four weeks, and its label says to consider stopping once amyloid plaques fall to minimal levels on PET imaging. Leqembi is given either as an infusion every two weeks or as a weekly injection under the skin with an autoinjector, and after 18 months it can continue at the starting dose or move to a maintenance dose. Their MRI monitoring schedules also differ.[2, 3]
The evidence behind each approval
Kisunla. Study 1 (NCT04437511) was a double-blind, placebo-controlled study in 1,736 patients with confirmed amyloid pathology at the mild cognitive impairment or mild dementia stage. The primary measure was change in the iADRS score at 76 weeks, and the label reports a statistically significant reduction in clinical decline compared with placebo. Study 2 compared dose schedules; the recommended schedule, which starts at 350 mg, lowered amyloid plaque comparably with fewer ARIA-related events.[2]
Leqembi. Study 2 (NCT03887455) was a double-blind, placebo-controlled study in 1,795 patients with confirmed amyloid pathology at the mild cognitive impairment or mild dementia stage. The primary measure was change in the CDR-SB score at 18 months, and the label reports that Leqembi met it and reduced clinical decline compared with placebo. Study 1 (NCT01767311) enrolled 856 patients. The under-the-skin form is approved on comparable drug levels and amyloid reduction, not on a separate outcome trial.[3]
No head-to-head trial. Neither US label reports a study that compared Kisunla directly with Leqembi. The trials used different entry rules and different main measures (iADRS for Kisunla, CDR-SB for Leqembi), so their results cannot be set side by side to decide which medicine works better.
Using one after the other
Neither label describes using the two together or switching from one to the other. Both labels carry the same class boxed warning about ARIA, and both say ApoE ε4 testing should be done before treatment. Your specialist decides which, if either, to use.[2, 3]
Safety: what the labels warn about
Both labels list warnings that the treating team monitors. The boxed warning row in the table above is the most serious level of warning on a US label.
- Kisunla: common side effects listed on the label include ARIA with swelling (ARIA-E), ARIA with small bleeds or iron deposits (ARIA-H microhemorrhage and superficial siderosis) and headache.[2]
- Leqembi: common side effects listed on the label include infusion-related reactions, ARIA with small bleeds (ARIA-H microhemorrhages), ARIA with swelling or fluid (ARIA-E) and headache; injection-related reactions also occurred with the under-the-skin form.[3]
Availability in the Gulf
- Kisunla: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.[6, 7]
Country guides: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman - Leqembi: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.[6, 7]
Country guides: Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman, Egypt
How families in the Gulf can access Kisunla or Leqembi
If the medicine is listed in your country. Ask your specialist and the hospital pharmacy about local supply first. A listing does not mean every hospital stocks it, but local supply is usually the fastest route and you may not need us.
If it is not registered. The usual legal route is a named-patient request: the treating hospital, on your specialist's written request, asks the national regulator for permission to import the medicine for one patient, using the US FDA approval as the reference. In Saudi Arabia the SFDA Special Access Program guidance covers these requests; in Bahrain, NHRA Circular 41 of 2020 sets the procedure. Other Gulf countries have their own procedures, which the hospital pharmacy confirms.[8, 9] Once approval is in place, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital pharmacy.
Before treatment starts. Both labels require confirmation of amyloid pathology and a recent brain MRI, and both say ApoE ε4 testing should be done first. The treating center must be able to do the follow-up brain MRIs on the schedule each label sets.[2, 3]
We give you a written timeline estimate once we see the hospital file. The regulator, the treatment center and the manufacturer set their own timelines.
What treatment costs
Quote on request. Your total cost depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and temperature-controlled shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only and we do not choose between medicines.
Ask us about Kisunla or Leqembi
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Which is better, Kisunla or Leqembi?
There is no head-to-head trial, so no one can say from the evidence that one is better. Both are approved for the same early stage of the disease, but they are given differently and have different MRI schedules. Your specialist decides which fits, based on test results, MRI findings, ApoE ε4 status and overall health.
What is the main difference between Kisunla and Leqembi?
Kisunla is an infusion every four weeks, and its label says to consider stopping once amyloid plaques fall to minimal levels on PET imaging. Leqembi is given either as an infusion every two weeks or as a weekly injection under the skin with an autoinjector, and after 18 months it can continue at the starting dose or move to a maintenance dose. Their MRI monitoring schedules also differ.
Are Kisunla and Leqembi available in Saudi Arabia or the UAE?
Kisunla: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). Leqembi: Saudi Arabia: listed in the SFDA drugs list (checked 17 October 2026). Abu Dhabi: has an active code in the Abu Dhabi DoH drug code list (checked 18 October 2026). UAE federal status, Kuwait, Qatar, Bahrain and Oman: not verified in a public register.
How can a family in the Gulf get Kisunla or Leqembi?
Ask the treating hospital about local supply first. If the medicine is not registered, the hospital can file a named-patient import request with the national regulator on your specialist's written request. Once approved, we arrange US supply to the hospital pharmacy.
How much do these medicines cost?
Quote on request. Your total cost, including the medicine, shipping, import steps and coordination, is quoted in writing for your case before you commit. No hidden charges.
Does Reserve Meds choose the medicine?
No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We do not diagnose, prescribe or choose between medicines. Your specialist and hospital make the medical decisions.
Sources
Checked on 18 October 2026. Labels, registers and regulator rules change. Your hospital pharmacy confirms the current position before filing.
- MedlinePlus (US National Library of Medicine): Alzheimer's Disease
- DailyMed (US National Library of Medicine): Kisunla (donanemab-azbt) US prescribing information, version published 2 January 2026
- DailyMed (US National Library of Medicine): Leqembi (lecanemab-irmb) US prescribing information, version published 27 July 2026
- Drugs@FDA: BLA 761248, Kisunla (donanemab-azbt), original approval 2 July 2024
- Drugs@FDA: BLA 761269, Leqembi (lecanemab-irmb), original approval 6 January 2023
- SFDA: Drugs List, public register (all 9,173 entries checked by brand name on 17 October 2026)
- Department of Health Abu Dhabi: drug code list Drugs.xlsx (release 26 September 2026, effective 2 October 2026; re-read on 18 October 2026)
- SFDA: Special Access Program (SAP) guidance, version 1.0
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines and pharmaceutical products
Related
- Kisunla: full drug page
- Leqembi: full drug page
- Alzheimer's disease: condition guide
- Named-patient access in the Gulf, explained
- Answers to common access questions
- Cross-border disclosures
- اقرأ هذه الصفحة بالعربية
This page is general health information, not medical advice. It does not replace a consultation with your doctor.