AMG0001

AnGes USA, Inc. · Phase 2 active Biologic Quality 45/100

AMG0001 is a Gene therapy Biologic drug developed by AnGes USA, Inc.. It is currently in Phase 2 development. Also known as: HGF plasmid, Collategene, beperminogene perplasmid.

AMG0001 delivers the hepatocyte growth factor (HGF) gene to stimulate new blood vessel formation in ischemic tissues.

Likelihood of approval

15.3% 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).

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	AMG0001
Also known as	HGF plasmid, Collategene, beperminogene perplasmid
Sponsor	AnGes USA, Inc.
Drug class	Gene therapy
Modality	Biologic
Phase	Phase 2

Mechanism of action

AMG0001 is a plasmid DNA encoding human hepatocyte growth factor (HGF). When administered, it promotes therapeutic angiogenesis by inducing the formation of new blood vessels and collateral circulation in ischemic limbs, potentially improving blood flow and reducing symptoms of peripheral arterial disease.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

• Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers (PHASE2)
• Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers (PHASE2)
• A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia (PHASE2)
• A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
• Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia (PHASE3)
• Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia (PHASE2)

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:

• AMG0001 CI brief — competitive landscape report
• AMG0001 updates RSS · CI watch RSS
• AnGes USA, Inc. portfolio CI

Frequently asked questions about AMG0001

What is AMG0001?

AMG0001 is a Gene therapy drug developed by AnGes USA, Inc..

How does AMG0001 work?

AMG0001 delivers the hepatocyte growth factor (HGF) gene to stimulate new blood vessel formation in ischemic tissues.

Who makes AMG0001?

AMG0001 is developed by AnGes USA, Inc. (see full AnGes USA, Inc. pipeline at /company/anges-usa-inc).

Is AMG0001 also known as anything else?

AMG0001 is also known as HGF plasmid, Collategene, beperminogene perplasmid.

What drug class is AMG0001 in?

AMG0001 belongs to the Gene therapy class. See all Gene therapy drugs at /class/gene-therapy.

What development phase is AMG0001 in?

AMG0001 is in Phase 2.

Related

• Drug class: All Gene therapy drugs
• Manufacturer: AnGes USA, Inc. — full pipeline
• Also known as: HGF plasmid, Collategene, beperminogene perplasmid