Last reviewed 2026-05-28 · How we verify

SAGE-217 low dose

Biogen · Phase 1 active Small molecule ✓ Verified May 2026

SAGE-217 low dose is a Small molecule drug developed by Biogen. It is currently in Phase 1 development.

SAGE-217 is a small molecule that acts as a positive allosteric modulator of the GABA-A receptor, an anion channel. This medication was studied in a randomized, double-blind, multiple dose, 3-way crossover study in healthy adults to assess its pharmacodynamic effects using an insomnia model.

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	SAGE-217 low dose
Sponsor	Biogen
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model (PHASE1)

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:

SAGE-217 low dose CI brief — competitive landscape report
SAGE-217 low dose updates RSS · CI watch RSS
Biogen portfolio CI

Frequently asked questions about SAGE-217 low dose

What is SAGE-217 low dose?

SAGE-217 low dose is a Small molecule drug developed by Biogen.

Who makes SAGE-217 low dose?

SAGE-217 low dose is developed by Biogen (see full Biogen pipeline at /company/biogen).

What development phase is SAGE-217 low dose in?

SAGE-217 low dose is in Phase 1.

Manufacturer: Biogen — full pipeline

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