Who are BF2.649 (pitolisant)'s main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Wakix, Floxin, Syncurine, Eramin, Merislon, Betahistine Extended Release formulation.

How often does this brief refresh?

Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

BF2.649 (pitolisant) — Competitive Intelligence Brief

BF2.649 (pitolisant) (BF2.649 (pitolisant)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Histamine H3 receptor antagonist. Area: Neurology.

phase 3 Histamine H3 receptor antagonist H3 receptor Neurology Small molecule Live · refreshed every 30 min

Target snapshot

BF2.649 (pitolisant) (BF2.649 (pitolisant)) — Bioprojet. Pitolisant is a selective histamine H3 receptor antagonist that increases histamine release in the brain to promote wakefulness.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
BF2.649 (pitolisant) TARGET	BF2.649 (pitolisant)	Bioprojet	phase 3	Histamine H3 receptor antagonist	H3 receptor
Wakix	PITOLISANT	Harmony	marketed		Histamine H3 receptor	2019-01-01
Floxin	OFLOXACIN		marketed	Quinolone Antimicrobial [EPC]	Histamine H3 receptor	1990-01-01
Syncurine	DECAMETHONIUM		marketed	decamethonium	Acetylcholinesterase, Histamine H3 receptor, Muscarinic acetylcholine receptor M2	1975-01-01
Eramin	HISTAMINE	Eli Lilly	marketed	histamine	Histamine H3 receptor	1939-01-01
Merislon	Merislon	Zhan Yunfan	marketed		Histamine H3 receptor, Histamine H3 receptor
Betahistine Extended Release formulation	Betahistine Extended Release formulation	OBEcure Ltd.	marketed	Histamine H1 receptor agonist / H3 receptor antagonist	Histamine H1 receptor, Histamine H3 receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Histamine H3 receptor antagonist class)

Bioprojet · 3 drugs in this class
Harmony Biosciences Management, Inc. · 3 drugs in this class

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Cite this brief

Drug Landscape (2026). BF2.649 (pitolisant) — Competitive Intelligence Brief. https://druglandscape.com/ci/bf2-649-pitolisant. Accessed 2026-05-13.

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