Last reviewed 2026-06-02 · How we verify

Belbuca 600 µg

BioDelivery Sciences International · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 10/100

Belbuca 600 µg is a Small molecule drug developed by BioDelivery Sciences International. It is currently in Phase 1 development.

Belbuca is a small molecule medication used to treat respiratory depression. It is available in various doses, including 300 µg, 600 µg, and 900 µg, which have been studied in 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	Belbuca 600 µg
Sponsor	BioDelivery Sciences International
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Euphoric Mood
Headache
Vomiting
Fatigue
Upper respiratory tract infection
Fall
Dizziness
Hyperhidrosis
Supraventricular extrasystoles
Rhythm idioventricular
Bradycardia
Visual Impairment

Competitive intelligence

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

Belbuca 600 µg CI brief — competitive landscape report
Belbuca 600 µg updates RSS · CI watch RSS
BioDelivery Sciences International portfolio CI

Frequently asked questions about Belbuca 600 µg

What is Belbuca 600 µg?

Belbuca 600 µg is a Small molecule drug developed by BioDelivery Sciences International.

Who makes Belbuca 600 µg?

Belbuca 600 µg is developed by BioDelivery Sciences International (see full BioDelivery Sciences International pipeline at /company/biodelivery-sciences-international).

What development phase is Belbuca 600 µg in?

Belbuca 600 µg is in Phase 1.

What are the side effects of Belbuca 600 µg?

Common side effects of Belbuca 600 µg include Euphoric Mood, Headache, Vomiting, Fatigue, Upper respiratory tract infection, Fall.

Manufacturer: BioDelivery Sciences International — full pipeline

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