Who are Open-label pitolisant's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Pitolisant tablet, BF2.649, BF2.649 (pitolisant), Double-blind pitolisant, BF2.649 add on Modafinil.

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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

Open-label pitolisant — Competitive Intelligence Brief

Open-label pitolisant (Open-label pitolisant) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Histamine H3 receptor antagonist. Area: Neurology.

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

Target snapshot

Open-label pitolisant (Open-label pitolisant) — Harmony Biosciences Management, Inc.. Pitolisant is a selective histamine H3 receptor antagonist that increases wakefulness by blocking inhibitory histamine signaling in the brain.

Comparator set (5 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
Open-label pitolisant TARGET	Open-label pitolisant	Harmony Biosciences Management, Inc.	phase 3	Histamine H3 receptor antagonist	H3 receptor (histamine H3 receptor)
Pitolisant tablet	Pitolisant tablet	Harmony Biosciences Management, Inc.	phase 3	Histamine H3 receptor antagonist	H3 receptor
BF2.649	BF2.649	Bioprojet	phase 3	Histamine H3 receptor antagonist	H3 receptor
BF2.649 (pitolisant)	BF2.649 (pitolisant)	Bioprojet	phase 3	Histamine H3 receptor antagonist	H3 receptor
Double-blind pitolisant	Double-blind pitolisant	Harmony Biosciences Management, Inc.	phase 3	Histamine H3 receptor antagonist	H3 receptor
BF2.649 add on Modafinil	BF2.649 add on Modafinil	Bioprojet	phase 3	Histamine H3 receptor antagonist	Histamine H3 receptor (H3R)

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). Open-label pitolisant — Competitive Intelligence Brief. https://druglandscape.com/ci/open-label-pitolisant. Accessed 2026-05-13.

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