Last reviewed 2026-05-31 · How we verify

BG00010 IV

Biogen · Phase 1 active Biologic ✓ Verified May 2026

BG00010 IV is a Biologic drug developed by Biogen. It is currently in Phase 1 development. Also known as: Neublastin.

BG00010, also known as Neublastin, is a small molecule being studied for its safety and efficacy in treating conditions such as sciatica, painful lumbar radiculopathy, and radiculopathy. It has been administered intravenously in a clinical trial to assess its safety, tolerability, and pharmacokinetics.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Biogen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	BG00010 IV
Also known as	Neublastin
Sponsor	Biogen
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

BG00010 IV CI brief — competitive landscape report
BG00010 IV updates RSS · CI watch RSS
Biogen portfolio CI

Frequently asked questions about BG00010 IV

What is BG00010 IV?

BG00010 IV is a Biologic drug developed by Biogen.

Who makes BG00010 IV?

BG00010 IV is developed by Biogen (see full Biogen pipeline at /company/biogen).

Is BG00010 IV also known as anything else?

BG00010 IV is also known as Neublastin.

What development phase is BG00010 IV in?

BG00010 IV is in Phase 1.

Manufacturer: Biogen — full pipeline
Also known as: Neublastin

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