Last reviewed 2026-05-24 · How we verify

Adrecizumab

Radboud University Medical Center · Phase 2 active Small molecule ✓ Verified May 2026

Adrecizumab is a Small molecule drug developed by Radboud University Medical Center. It is currently in Phase 2 development. Also known as: HAM8101 (Adrecizumab).

Adrecizumab is an antibody that stabilizes pro-adrenomedullin, a protein involved in various physiological processes. It has been studied in clinical trials for conditions such as COVID-19, acute heart failure, cardiogenic shock, and endothelial dysfunction, among others.

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	Adrecizumab
Also known as	HAM8101 (Adrecizumab)
Sponsor	Radboud University Medical Center
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (PHASE2)
Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (PHASE2)
Adrecizumab in Cardiogenic Shock (PHASE2, PHASE3)
Adrecizumab Dose Escalation Safety and Tolerability Evaluation (ADESTE) (PHASE2)
Adrecizumab-LPS Study (PHASE1)
Adrecizumab Phase 1 Trial (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:

Adrecizumab CI brief — competitive landscape report
Adrecizumab updates RSS · CI watch RSS
Radboud University Medical Center portfolio CI

Frequently asked questions about Adrecizumab

What is Adrecizumab?

Adrecizumab is a Small molecule drug developed by Radboud University Medical Center.

Who makes Adrecizumab?

Adrecizumab is developed by Radboud University Medical Center (see full Radboud University Medical Center pipeline at /company/radboud-university-medical-center).

Is Adrecizumab also known as anything else?

Adrecizumab is also known as HAM8101 (Adrecizumab).

What development phase is Adrecizumab in?

Adrecizumab is in Phase 2.

Manufacturer: Radboud University Medical Center — full pipeline
Therapeutic area: All drugs in Other
Also known as: HAM8101 (Adrecizumab)

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