Last reviewed 2026-04-22 · How we verify

Buprenorphine +OTP

Friends Research Institute, Inc. · Phase 3 active Small molecule

Buprenorphine +OTP is a Partial mu-opioid receptor agonist Small molecule drug developed by Friends Research Institute, Inc.. It is currently in Phase 3 development for Opioid use disorder (maintenance treatment), Opioid dependence. Also known as: Suboxone.

Buprenorphine is a partial mu-opioid receptor agonist combined with opioid treatment program (OTP) services to reduce opioid use disorder symptoms and cravings.

Buprenorphine is a partial mu-opioid receptor agonist combined with opioid treatment program (OTP) services to reduce opioid use disorder symptoms and cravings. Used for Opioid use disorder (maintenance treatment), Opioid dependence.

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	Buprenorphine +OTP
Also known as	Suboxone
Sponsor	Friends Research Institute, Inc.
Drug class	Partial mu-opioid receptor agonist
Target	Mu-opioid receptor (μ-OR)
Modality	Small molecule
Therapeutic area	Psychiatry / Addiction Medicine
Phase	Phase 3

Mechanism of action

Buprenorphine binds with high affinity to mu-opioid receptors in the central nervous system, producing partial agonist effects that reduce withdrawal symptoms and cravings while having a lower abuse potential than full opioid agonists. When combined with OTP (opioid treatment program), it is delivered as part of a comprehensive medication-assisted treatment (MAT) regimen that includes counseling and psychosocial support to address opioid use disorder.

Approved indications

Opioid use disorder (maintenance treatment)
Opioid dependence

Common side effects

Headache
Constipation
Nausea
Insomnia
Sweating
Respiratory depression

Key clinical trials

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:

Buprenorphine +OTP CI brief — competitive landscape report
Buprenorphine +OTP updates RSS · CI watch RSS
Friends Research Institute, Inc. portfolio CI

Frequently asked questions about Buprenorphine +OTP

What is Buprenorphine +OTP?

Buprenorphine +OTP is a Partial mu-opioid receptor agonist drug developed by Friends Research Institute, Inc., indicated for Opioid use disorder (maintenance treatment), Opioid dependence.

How does Buprenorphine +OTP work?

Buprenorphine is a partial mu-opioid receptor agonist combined with opioid treatment program (OTP) services to reduce opioid use disorder symptoms and cravings.

What is Buprenorphine +OTP used for?

Buprenorphine +OTP is indicated for Opioid use disorder (maintenance treatment), Opioid dependence.

Who makes Buprenorphine +OTP?

Buprenorphine +OTP is developed by Friends Research Institute, Inc. (see full Friends Research Institute, Inc. pipeline at /company/friends-research-institute-inc).

Is Buprenorphine +OTP also known as anything else?

Buprenorphine +OTP is also known as Suboxone.

What drug class is Buprenorphine +OTP in?

Buprenorphine +OTP belongs to the Partial mu-opioid receptor agonist class. See all Partial mu-opioid receptor agonist drugs at /class/partial-mu-opioid-receptor-agonist.

What development phase is Buprenorphine +OTP in?

Buprenorphine +OTP is in Phase 3.

What are the side effects of Buprenorphine +OTP?

Common side effects of Buprenorphine +OTP include Headache, Constipation, Nausea, Insomnia, Sweating, Respiratory depression.

What does Buprenorphine +OTP target?

Buprenorphine +OTP targets Mu-opioid receptor (μ-OR) and is a Partial mu-opioid receptor agonist.

Drug class: All Partial mu-opioid receptor agonist drugs
Target: All drugs targeting Mu-opioid receptor (μ-OR)
Manufacturer: Friends Research Institute, Inc. — full pipeline
Therapeutic area: All drugs in Psychiatry / Addiction Medicine
Indication: Drugs for Opioid use disorder (maintenance treatment)
Indication: Drugs for Opioid dependence
Also known as: Suboxone

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