Last reviewed 2026-05-27 · How we verify

Tanruprubart

Annexon, Inc. · Phase 3 active Small molecule ✓ Verified May 2026

Tanruprubart is a Small molecule drug developed by Annexon, Inc.. It is currently in Phase 3 development. Also known as: ANX005.

Tanruprubart, also known as ANX005, is being studied in an open-label clinical trial for the treatment of Guillain-Barre Syndrome. This trial, known as the FORWARD Study, is being conducted by Annexon, Inc.

Likelihood of approval

58.3% 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).

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	Tanruprubart
Also known as	ANX005
Sponsor	Annexon, Inc.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study) (PHASE3)

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:

Tanruprubart CI brief — competitive landscape report
Tanruprubart updates RSS · CI watch RSS
Annexon, Inc. portfolio CI

Frequently asked questions about Tanruprubart

What is Tanruprubart?

Tanruprubart is a Small molecule drug developed by Annexon, Inc..

Who makes Tanruprubart?

Tanruprubart is developed by Annexon, Inc. (see full Annexon, Inc. pipeline at /company/annexon-inc).

Is Tanruprubart also known as anything else?

Tanruprubart is also known as ANX005.

What development phase is Tanruprubart in?

Tanruprubart is in Phase 3.

Manufacturer: Annexon, Inc. — full pipeline
Therapeutic area: All drugs in Other
Also known as: ANX005

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