AVP-786-42.63 — Competitive Intelligence Brief

AVP-786-42.63 (AVP-786-42.63) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Sigma-1 receptor agonist. Area: Neurology.

phase 3 Sigma-1 receptor agonist Sigma-1 receptor Neurology Small molecule

Target snapshot

AVP-786-42.63 (AVP-786-42.63) — Otsuka Pharmaceutical Development & Commercialization, Inc.. AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neuroinflammation and neurodegeneration.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
AVP-786-42.63 TARGET	AVP-786-42.63	Otsuka Pharmaceutical Development & Commercialization, Inc.	phase 3	Sigma-1 receptor agonist	Sigma-1 receptor
QUINIDINE	QUINIDINE		marketed		sigma-1 receptor, NMDA receptor, CYP2D6	1950-01-01
Dextromethorphan HBr	Dextromethorphan HBr	Galera Therapeutics, Inc.	marketed	NMDA receptor antagonist; sigma-1 receptor agonist	NMDA receptor; sigma-1 receptor
placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan	placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan	Montefiore Medical Center	marketed	Combination cold and cough remedy	H1 receptor (diphenhydramine); alpha-1 adrenergic receptor (phenylephrine); sigma-1 receptor and NMDA receptor (dextromethorphan)
diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan	diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan	Montefiore Medical Center	marketed	Combination cold/cough/allergy remedy	H1 histamine receptor (diphenhydramine); alpha-1 adrenergic receptor (phenylephrine); NMDA receptor and sigma-1 receptor (dextromethorphan)
Dextromethorphan Oral Solution	Dextromethorphan Oral Solution	Helsinki University Central Hospital	marketed	Non-opioid antitussive	NMDA receptor antagonist; sigma-1 receptor
Dextromethorphan hydrobromide with guaifenesin	Dextromethorphan hydrobromide with guaifenesin	Washington University School of Medicine	marketed	Antitussive/expectorant combination	Sigma-1 receptor, NMDA receptor (dextromethorphan); non-specific expectorant mechanism (guaifenesin)

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 (Sigma-1 receptor agonist class)

1. Otsuka Pharmaceutical Development & Commercialization, Inc. · 3 drugs in this class
2. Anavex Life Sciences Corp. · 2 drugs in this class