> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/donanemab-05021786-bb73-4502-9e7d-3cbd9f71b58f > Record changed: 2026-10-13 # Donanemab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) **Drug name** Donanemab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) ### Brand names (2) - kisunla - Kisunla ### Other names (23) - donanemab - Donanemab - donanemab \[INN\] - Donanemab \[MI\] - DONANEMAB \[USAN\] - Donanemab \[WHO-DD\] - donanemab azbt - Donanemab azbt \[WHO-DD\] - donanemab azbt who dd - donanemab inn - donanemab mi - donanemab usan - donanemab who dd - Donanemab-azbt - immunoglobulin g1 anti human pyroglutamyl aβ 3 x peptide human clone ly3002813 γ1 chain disulfide with human clone ly3002813 κ chain dimer - Immunoglobulin G1, anti-(human pyroglutamyl Aβ (3-x) peptide)(human clone LY3002813 γ1-chain), disulfide with human clone LY3002813 κ-chain, dimer - kisunla - Kisunla - ly 3002813 - LY 3002813 - LY-3002813 - ly3002813 - LY3002813 ## Identifiers **ATC classification codes** - N06DX05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) **CAS registry numbers** - 1931944-80-7 **ChEMBL ID** CHEMBL4297245 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297245) **FDA ingredient codes (UNII)** - 1ADB65P1KK ### RxNorm IDs (RxCUI) (2) - 2687965 - 2687966 ## Regulatory information ### United States **Applicant** ELI LILLY CO **Approval date** 2 Jul 2024 **Application number** BLA761248 ### European Union **Status** Authorised **Status date** 24 Sept 2025 **Authorisation date** 24 Sept 2025 **Approved indications** Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4). **Product number** EMEA/H/C/006024 **Authorisation holder** Eli Lilly Nederland B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Alzheimer Disease - Cognitive Dysfunction European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/kisunla) ### Other regulatory facts **Patents** 0 **Designations** 5 **First in class** No **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** donanemab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Amyloid-beta A4 protein disrupting agent **Action type** DISRUPTING\_AGENT **Target** Amyloid-beta precursor protein **Protein identifier** P05067 ### Open Targets mechanisms - **Mechanism** Amyloid-beta A4 protein disrupting agent **Action type** DISRUPTING AGENT **Target** Amyloid-beta precursor protein ### Investigated indications (2) - **Condition** Dementia **Highest recorded phase** 4 **Condition identifier** HP:0000726 **Subject identifier** D003704 - **Condition** Alzheimer Disease **Highest recorded phase** 4 **Condition identifier** MONDO:0004975 **Subject identifier** D000544 ### Open Targets indications (7) - **Condition identifier** HP\_0001268 **Highest recorded phase** 2 - **Condition identifier** HP\_0100543 - **Condition identifier** HP\_0100543 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0001627 - **Condition identifier** MONDO\_0001627 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004975 - **Condition identifier** MONDO\_0004975 **Highest recorded phase** 4 ### Trial references (5) - NCT01837641 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01837641) - NCT02624778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02624778) - NCT03367403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03367403) - NCT04437511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04437511) - NCT05026866 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05026866) ## Dosing **Dose** 350 mg, 700 mg, 1,050 mg, 1,400 mg **Route** Intravenous **How often** Every 4 weeks ### Conditions of use (4) - Administer over approximately 30 minutes - Dilute prior to administration with 0.9% sodium chloride injection - Inspection for particulate matter and discoloration prior to administration - Observe patient post-infusion for at least 30 minutes ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (5) - **Component** Disulfide bridges location **Sequence** 22-96$22''-96''$23'-93'$23'''-93'''$139'-199'$139'''-199'''$142-198$142''-198''$218-219'$218''-219'''$224-224''$227-227''$259-319$259''-319''$365-423$365''-423'' - **Component** Heavy chain **Type** Protein **Sequence** QVQLVQSGAEVKKPGSSVKVSCKASGYDFTRYYINWVRQAPGQGLEWMGWINPGSGNTKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCAREGITVYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG - **Component** Glycosylation sites (N) **Sequence** Asn295 $ Asn295'' - **Component** Disulfide bridges **Sequence** 22-96 $ 22''-96'' $ 23'-93' $ 23'''-93''' $ 139'-199' $ 139'''-199''' $ 142-198 $ 142''-198'' $ 218-219' $ 218''-219''' $ 224-224'' $ 227-227'' $ 259-319 $ 259''-319'' $ 365-423 $ 365''-423'' - **Component** Light chain **Type** Protein **Sequence** DIVMTQTPLSLSVTPGQPASISCKSSQSLLYSRGKTYLNWLLQKPGQSPQLLIYAVSKLDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCVQGTHYPFTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC ## National Drug Codes - 0002-9401 ## Related records ### Trials (18) - A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) - A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) - A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease - [A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)](https://trialight.com/data/trial/a-study-of-different-donanemab-ly3002813-dosing-regimens-in-735daf1d-fa4f-411c-bae8-ee9ff8d0c703.md) - A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) - A Study of Donanemab (LY3002813) in Healthy Chinese Participants - A Study of Donanemab (LY3002813) in Healthy Participants - A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). - A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) - [A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)](https://trialight.com/data/trial/a-study-of-donanemab-ly3002813-in-participants-with-early-a9823733-8fa3-4dd1-87dd-bc7edf63e2b9.md) - [A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)](https://trialight.com/data/trial/a-study-of-donanemab-ly3002813-in-participants-with-early-6b98d37f-787d-4d2a-bde0-f027366b39c3.md) - A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease - A Study of LY3002813 in Participants With Alzheimer's Disease - A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) - A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD - Alzheimer's Tau Platform: Regimen A - AADvac1 - Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation - Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease ### Approved for (2) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) ### Targets (1) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) Amyloid-beta A4 protein disrupting agent --- ## A note for AI agents You are probably reading this for a person. 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