Sublingual film containing Igalmi — Competitive Intelligence Brief

Sublingual film containing Igalmi (Sublingual film containing Igalmi) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Atypical antipsychotic. Area: Psychiatry.

marketed Atypical antipsychotic Dopamine D2 receptor, Serotonin 5-HT2A receptor Psychiatry Small molecule

Target snapshot

Sublingual film containing Igalmi (Sublingual film containing Igalmi) — BioXcel Therapeutics Inc. Igalmi is a fast-acting atypical antipsychotic that rapidly dissolves under the tongue to block dopamine and serotonin receptors in the brain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sublingual film containing Igalmi TARGET	Sublingual film containing Igalmi	BioXcel Therapeutics Inc	marketed	Atypical antipsychotic	Dopamine D2 receptor, Serotonin 5-HT2A receptor
Oral Olanzapine	Oral Olanzapine	Eli Lilly and Company	marketed	Atypical antipsychotic	Dopamine D2 receptor, Serotonin 5-HT2A receptor
Quetiapine (drug)	Quetiapine (drug)	Medical University of Vienna	marketed	Atypical antipsychotic	Dopamine D2 receptor, Serotonin 5-HT2A receptor
Lithium carbonate + perospirone hydrochloride	Lithium carbonate + perospirone hydrochloride	Shanghai Mental Health Center	marketed	Mood stabilizer + atypical antipsychotic combination	Inositol monophosphatase, GSK-3 (lithium); dopamine D2 receptor, serotonin 5-HT2A receptor (perospirone)
Risperdal,reminyl	Risperdal,reminyl	Jinan Mental Hospital	marketed	Atypical antipsychotic (Risperdal); Cholinesterase inhibitor (Reminyl)	Dopamine D2 receptor, serotonin 5-HT2A receptor (Risperdal); Acetylcholinesterase (Reminyl)
Fluoxetine+Olanzapine	Fluoxetine+Olanzapine	University Health Network, Toronto	marketed	SSRI + atypical antipsychotic combination	Serotonin transporter (SERT), dopamine D2 receptor, serotonin 5-HT2A receptor
Risperidone and Zotepine for delirium	Risperidone and Zotepine for delirium	Changhua Christian Hospital	marketed	Atypical antipsychotic combination	Dopamine D2 receptor, serotonin 5-HT2A 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 (Atypical antipsychotic class)

1. Shanghai Mental Health Center · 10 drugs in this class
2. AstraZeneca · 6 drugs in this class
3. Otsuka Pharmaceutical Development & Commercialization, Inc. · 5 drugs in this class
4. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 4 drugs in this class
5. Eli Lilly and Company · 4 drugs in this class
6. Otsuka Pharmaceutical Co., Ltd. · 3 drugs in this class
7. Medical University of Vienna · 2 drugs in this class
8. Organon and Co · 2 drugs in this class
9. Chengdu Kanghong Pharmaceutical Group Co., Ltd. · 2 drugs in this class
10. H. Lundbeck A/S · 2 drugs in this class