Last reviewed 2026-05-28 · How we verify

High Bup/Nal Dose

New York State Psychiatric Institute · Phase 3 active Small molecule Under review

High Bup/Nal Dose is a Opioid agonist-antagonist combination Small molecule drug developed by New York State Psychiatric Institute. It is currently in Phase 3 development for Opioid use disorder. Also known as: Suboxone.

A combination of buprenorphine (partial opioid agonist) and naloxone (opioid antagonist) at higher doses to treat opioid use disorder with improved efficacy and safety.

Buprenorphine, a small molecule, is used to treat opioid-related disorders. It is often administered in combination with naloxone, a medication that counteracts opioid effects, to prevent misuse.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	High Bup/Nal Dose
Also known as	Suboxone
Sponsor	New York State Psychiatric Institute
Drug class	Opioid agonist-antagonist combination
Target	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Modality	Small molecule
Therapeutic area	Psychiatry / Addiction Medicine
Phase	Phase 3

Mechanism of action

Buprenorphine acts as a partial agonist at the mu-opioid receptor, providing sufficient opioid activity to prevent withdrawal while having a ceiling effect that reduces overdose risk. Naloxone is included as an antagonist to deter intravenous misuse. At higher doses than standard formulations, this combination aims to improve treatment outcomes and reduce illicit opioid use in patients with opioid use disorder.

Approved indications

Opioid use disorder

Common side effects

Headache
Nausea
Constipation
Insomnia
Sweating

Key clinical trials

Abuse Liability of Suboxone Versus Subutex (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

High Bup/Nal Dose CI brief — competitive landscape report
High Bup/Nal Dose updates RSS · CI watch RSS
New York State Psychiatric Institute portfolio CI

Frequently asked questions about High Bup/Nal Dose

What is High Bup/Nal Dose?

High Bup/Nal Dose is a Opioid agonist-antagonist combination drug developed by New York State Psychiatric Institute, indicated for Opioid use disorder.

How does High Bup/Nal Dose work?

A combination of buprenorphine (partial opioid agonist) and naloxone (opioid antagonist) at higher doses to treat opioid use disorder with improved efficacy and safety.

What is High Bup/Nal Dose used for?

High Bup/Nal Dose is indicated for Opioid use disorder.

Who makes High Bup/Nal Dose?

High Bup/Nal Dose is developed by New York State Psychiatric Institute (see full New York State Psychiatric Institute pipeline at /company/new-york-state-psychiatric-institute).

Is High Bup/Nal Dose also known as anything else?

High Bup/Nal Dose is also known as Suboxone.

What drug class is High Bup/Nal Dose in?

High Bup/Nal Dose belongs to the Opioid agonist-antagonist combination class. See all Opioid agonist-antagonist combination drugs at /class/opioid-agonist-antagonist-combination.

What development phase is High Bup/Nal Dose in?

High Bup/Nal Dose is in Phase 3.

What are the side effects of High Bup/Nal Dose?

Common side effects of High Bup/Nal Dose include Headache, Nausea, Constipation, Insomnia, Sweating.

What does High Bup/Nal Dose target?

High Bup/Nal Dose targets Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism) and is a Opioid agonist-antagonist combination.

Drug class: All Opioid agonist-antagonist combination drugs
Target: All drugs targeting Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Manufacturer: New York State Psychiatric Institute — full pipeline
Therapeutic area: All drugs in Psychiatry / Addiction Medicine
Indication: Drugs for Opioid use disorder
Also known as: Suboxone

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing