Donanemab - Revision history

MDElliottMD: Tier 1 taxonomy consolidation: removed redundant Category:Anti-dementia (canonical already present); removed redundant Category:Anti-Amyloid Antibodies (canonical already present)

2026-05-21T17:01:54Z

Tier 1 taxonomy consolidation: removed redundant Category:Anti-dementia (canonical already present); removed redundant Category:Anti-Amyloid Antibodies (canonical already present)

← Older revision		Revision as of 17:01, 21 May 2026
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	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	~~[[Category:Anti-dementia]]~~
	[[Category:Anti-Amyloid Monoclonal Antibodies]]		[[Category:Anti-Amyloid Monoclonal Antibodies]]
	~~[[Category:Anti-Amyloid Antibodies]]~~
	[[Category:Alzheimer Disease Medicines]]		[[Category:Alzheimer Disease Medicines]]

MDElliottMD: Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

2026-05-19T03:16:07Z

Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

← Older revision		Revision as of 03:16, 19 May 2026
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	\| pregnancy = Limited data		\| pregnancy = Limited data
	\| legal = Rx; ARIA monitoring required		\| legal = Rx; ARIA monitoring required
	\| intro = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ — an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.		\| intro = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ, an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.

	Pivotal trial (TRAILBLAZER-ALZ 2): ~35% slowing of cognitive decline on integrated Alzheimer Disease Rating Scale (iADRS) over 18 months. The trial enriched for tau-positive patients. As with other anti-amyloid mAbs, ARIA is the principal safety concern, with higher rates than lecanemab (especially ARIA-E in ~25% of treated patients).		Pivotal trial (TRAILBLAZER-ALZ 2): ~35% slowing of cognitive decline on integrated Alzheimer Disease Rating Scale (iADRS) over 18 months. The trial enriched for tau-positive patients. As with other anti-amyloid mAbs, ARIA is the principal safety concern, with higher rates than lecanemab (especially ARIA-E in ~25% of treated patients).

Maintenance script: Expand Donanemab with Stahl-sourced detail (with skepticism)

2026-05-16T02:03:47Z

Expand Donanemab with Stahl-sourced detail (with skepticism)

← Older revision		Revision as of 02:03, 16 May 2026
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	{{MedTemplate		{{MedTemplate
	~~\| generic = Donanemab~~		\| brand = Kisunla
	\| brand = Kisunla		\| classes = Anti-amyloid beta (Aβ) monoclonal antibody, targets pyroglutamated Aβ in plaques
	~~\| structure =~~		\| mechanism = Humanized IgG1 monoclonal antibody specifically targeting '''N-terminally truncated, pyroglutamated Aβ''' (an early modified form found primarily in established plaques). Designed for rapid plaque clearance. Patients can stop treatment once amyloid is cleared on PET (unique among approved anti-amyloid mAbs).
	\| classes = Anti-~~dementia~~, ~~Monoclonal antibody~~		\| uses = Alzheimer disease (MCI or mild dementia stage), FDA-approved July 2024
	\| mechanism = ~~Amyloid~~-~~beta~~ plaque-~~clearing antibody~~		\| starting_dose = 700 mg IV q4w × 3 doses, then 1400 mg IV q4w; may discontinue when amyloid PET shows clearance
	\| uses =		\| preparations = 350 mg/20 mL vial for IV infusion
	\| starting_dose =		\| fda_max = 1400 mg q4w
	\| preparations =		\| routes = IV infusion every 4 weeks
	\| fda_max =		\| onset = Amyloid PET clearance within months; cognitive benefit over 18 months
	\| routes =		\| duration = Treatment can be discontinued upon achieving amyloid clearance
	\| onset =		\| halflife = ~12.1 days
	\| duration =		\| bioavailability = 100% (IV)
	\| halflife =		\| pregnancy = Limited data
	\| bioavailability =		\| legal = Rx; ARIA monitoring required
	\| pregnancy =		\| intro = '''Donanemab''' (brand name Kisunla) is a humanized monoclonal antibody targeting N-terminally truncated, pyroglutamated Aβ — an Aβ form found predominantly in established plaques. FDA-approved in July 2024 for Alzheimer disease (MCI/mild AD). Unique among approved anti-amyloid mAbs: patients can '''discontinue treatment once amyloid PET shows plaque clearance''', typically within 12-18 months. This stop-criterion (a finite course rather than indefinite biweekly infusions like lecanemab) is donanemab's main clinical advantage.
	\| legal =
	\| intro =		Pivotal trial (TRAILBLAZER-ALZ 2): ~35% slowing of cognitive decline on integrated Alzheimer Disease Rating Scale (iADRS) over 18 months. The trial enriched for tau-positive patients. As with other anti-amyloid mAbs, ARIA is the principal safety concern, with higher rates than lecanemab (especially ARIA-E in ~25% of treated patients).
	~~\| pharmacokinetics =~~		\| pharmacodynamics= Humanized IgG1 targeting pyroglutamated Aβ (Aβ3-42(pE)). Aggressive plaque clearance via microglial phagocytosis.
	\| pharmacodynamics =		\| effects = ARIA-E (~24-27% in trials), ARIA-H. Some symptomatic ARIA cases including deaths reported. Infusion reactions. Headache. APOE ε4 carriers at higher ARIA risk.
	~~\| indications =~~		\| interactions = <pharmaInteractions/>
	~~\| dosing~~ =
	\| effects =
	\| interactions = <pharmaInteractions/>
	~~\| pregnancy_details =~~
	~~\| monitoring =~~
	~~\| counseling =~~
	~~\| anecdotes =~~
	~~\| seealso =~~
	~~\| references =~~
	}}		}}


	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]
	[[Category:Anti-Amyloid Monoclonal Antibodies]]		[[Category:Anti-Amyloid Monoclonal Antibodies]]
			[[Category:Anti-Amyloid Antibodies]]
			[[Category:Alzheimer Disease Medicines]]

MDElliottMD: Comprehensive categorization: +Anti-Amyloid Monoclonal Antibodies

2026-05-15T18:42:22Z

Comprehensive categorization: +Anti-Amyloid Monoclonal Antibodies

← Older revision		Revision as of 18:42, 15 May 2026
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	[[Category:Anti-Dementia Medicines]]		[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]
			[[Category:Anti-Amyloid Monoclonal Antibodies]]

MediaWiki default: Assign pharmacological categories from List_of_CNS-active_medicines

2026-05-14T15:07:06Z

Assign pharmacological categories from List_of_CNS-active_medicines

← Older revision		Revision as of 15:07, 14 May 2026
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	}}		}}


			[[Category:Anti-Dementia Medicines]]
	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]

MDElliottMD: Pharmacopedia: add

2026-05-14T03:30:49Z

Pharmacopedia: add <pharmaInteractions/>

← Older revision		Revision as of 03:30, 14 May 2026
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	\| dosing =		\| dosing =
	\| effects =		\| effects =
	\| interactions =		\| interactions = <pharmaInteractions/>
	\| pregnancy_details =		\| pregnancy_details =
	\| monitoring =		\| monitoring =

MDElliottMD: Pharmacopedia: remove contraindications parameter

2026-05-14T02:40:31Z

Pharmacopedia: remove contraindications parameter

← Older revision		Revision as of 02:40, 14 May 2026
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	\| dosing =		\| dosing =
	\| effects =		\| effects =
	~~\| contraindications =~~
	\| interactions =		\| interactions =
	\| pregnancy_details =		\| pregnancy_details =

MDElliottMD: Added empty fda_max parameter to MedTemplate call

2026-05-13T02:32:54Z

Added empty fda_max parameter to MedTemplate call

← Older revision		Revision as of 02:32, 13 May 2026
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	\| starting_dose =		\| starting_dose =
	\| preparations =		\| preparations =
			\| fda_max =
	\| routes =		\| routes =
	\| onset =		\| onset =
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	[[Category:Anti-dementia]]		[[Category:Anti-dementia]]

MDElliottMD: Expand stub to full MedTemplate parameter set

2026-05-13T01:00:00Z

Expand stub to full MedTemplate parameter set

@@ Line 1: / Line 1: @@
 {{MedTemplate
-| generic           = Donanemab
+| generic            = Donanemab
-| brand             = Kisunla
+| brand              = Kisunla
-| classes           = Anti-dementia, Monoclonal antibody
+| structure          =
-| mechanism         = Amyloid-beta plaque-clearing antibody
+| classes            = Anti-dementia, Monoclonal antibody
 }}
 [[Category:Anti-dementia]]

MDElliottMD: Auto-created stub

2026-05-13T00:00:00Z

Auto-created stub

New page

{{MedTemplate
| generic = Donanemab
| brand = Kisunla
| classes = Anti-dementia, Monoclonal antibody
| mechanism = Amyloid-beta plaque-clearing antibody
}}
[[Category:Anti-dementia]]