Last reviewed 2026-05-29 · How we verify

Buprenorphine LO

mads u werner · Phase 1 active Small molecule ✓ Verified May 2026 Quality 55/100

Buprenorphine LO is a Opioid partial agonist Small molecule drug developed by mads u werner. It is currently in Phase 1 development. Also known as: Temgesic.

Buprenorphine acts as a partial agonist at mu-opioid receptors and an antagonist at kappa-opioid receptors.

Buprenorphine LO is a small molecule that acts as a mu opioid receptor agonist. It is used to treat pain, as indicated by clinical trials.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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 LO
Also known as	Temgesic
Sponsor	mads u werner
Drug class	Opioid partial agonist
Modality	Small molecule
Phase	Phase 1

Mechanism of action

As a partial mu-opioid receptor agonist, buprenorphine produces analgesic effects and reduces opioid cravings while having a ceiling effect that limits respiratory depression. Its high receptor affinity and slow dissociation contribute to prolonged duration of action.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine (NA)

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 LO CI brief — competitive landscape report
Buprenorphine LO updates RSS · CI watch RSS
mads u werner portfolio CI

Frequently asked questions about Buprenorphine LO

What is Buprenorphine LO?

Buprenorphine LO is a Opioid partial agonist drug developed by mads u werner.

How does Buprenorphine LO work?

Buprenorphine acts as a partial agonist at mu-opioid receptors and an antagonist at kappa-opioid receptors.

Who makes Buprenorphine LO?

Buprenorphine LO is developed by mads u werner (see full mads u werner pipeline at /company/mads-u-werner).

Is Buprenorphine LO also known as anything else?

Buprenorphine LO is also known as Temgesic.

What drug class is Buprenorphine LO in?

Buprenorphine LO belongs to the Opioid partial agonist class. See all Opioid partial agonist drugs at /class/opioid-partial-agonist.

What development phase is Buprenorphine LO in?

Buprenorphine LO is in Phase 1.

Drug class: All Opioid partial agonist drugs
Manufacturer: mads u werner — full pipeline
Also known as: Temgesic

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