Last reviewed 2026-06-02 · How we verify

AZD0120 - Regimen 2

AstraZeneca · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 10/100

AZD0120 - Regimen 2 is a Biologic drug developed by AstraZeneca. It is currently in Phase 1 development.

AZD0120 is being studied in clinical trials for Multiple Sclerosis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies, and Rheumatoid Arthritis. AZD0120 - Regimen 2 is one of the interventions being tested in these trials.

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
AstraZeneca 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	AZD0120 - Regimen 2
Sponsor	AstraZeneca
Modality	Biologic
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Study of AZD0120 in Autoimmune Diseases (PHASE1)
An Open-label Study of AZD0120 in Adults With Multiple Sclerosis (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:

AZD0120 - Regimen 2 CI brief — competitive landscape report
AZD0120 - Regimen 2 updates RSS · CI watch RSS
AstraZeneca portfolio CI

Frequently asked questions about AZD0120 - Regimen 2

What is AZD0120 - Regimen 2?

AZD0120 - Regimen 2 is a Biologic drug developed by AstraZeneca.

Who makes AZD0120 - Regimen 2?

AZD0120 - Regimen 2 is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

What development phase is AZD0120 - Regimen 2 in?

AZD0120 - Regimen 2 is in Phase 1.

Manufacturer: AstraZeneca — full pipeline

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