Last reviewed 2026-04-23 · How we verify

AMG 853

Amgen · Phase 2 active Small molecule

AMG 853 is a Tissue factor inhibitor Small molecule drug developed by Amgen. It is currently in Phase 2 development for Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction.

AMG 853 is a recombinant, humanized monoclonal antibody that targets and neutralizes tissue factor.

AMG 853 is a recombinant, humanized monoclonal antibody that targets and neutralizes tissue factor. Used for Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction.

Likelihood of approval

16.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
Big-pharma sponsor +3.0pp
Amgen 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	AMG 853
Sponsor	Amgen
Drug class	Tissue factor inhibitor
Target	Tissue factor
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

AMG 853 works by binding to tissue factor, preventing its interaction with factor VIIa and subsequent activation of the coagulation cascade. This mechanism of action is intended to reduce the risk of thrombotic events in patients with cardiovascular disease.

Approved indications

Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction

Common side effects

Injection site reaction
Headache
Fatigue

Key clinical trials

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:

AMG 853 CI brief — competitive landscape report
AMG 853 updates RSS · CI watch RSS
Amgen portfolio CI

Frequently asked questions about AMG 853

What is AMG 853?

AMG 853 is a Tissue factor inhibitor drug developed by Amgen, indicated for Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction.

How does AMG 853 work?

AMG 853 is a recombinant, humanized monoclonal antibody that targets and neutralizes tissue factor.

What is AMG 853 used for?

AMG 853 is indicated for Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction.

Who makes AMG 853?

AMG 853 is developed by Amgen (see full Amgen pipeline at /company/amgen).

What drug class is AMG 853 in?

AMG 853 belongs to the Tissue factor inhibitor class. See all Tissue factor inhibitor drugs at /class/tissue-factor-inhibitor.

What development phase is AMG 853 in?

AMG 853 is in Phase 2.

What are the side effects of AMG 853?

Common side effects of AMG 853 include Injection site reaction, Headache, Fatigue.

What does AMG 853 target?

AMG 853 targets Tissue factor and is a Tissue factor inhibitor.

Drug class: All Tissue factor inhibitor drugs
Target: All drugs targeting Tissue factor
Manufacturer: Amgen — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Reduction of the risk of thrombotic events in patients with acute coronary syndrome or myocardial infarction

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