Last reviewed 2026-05-27 · How we verify

TEV-48574 Dose Regiment B

Teva Branded Pharmaceutical Products R&D LLC · Phase 2 active Small molecule ✓ Verified May 2026

TEV-48574 Dose Regiment B is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D LLC. It is currently in Phase 2 development. Also known as: duvakitug.

TEV-48574 is an antibody being studied for the treatment of Crohn Disease, Colitis, and Ulcerative Colitis. The study, NCT05668013, involves two dose regimens, A and B, of TEV-48574.

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	TEV-48574 Dose Regiment B
Also known as	duvakitug
Sponsor	Teva Branded Pharmaceutical Products R&D LLC
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (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:

TEV-48574 Dose Regiment B CI brief — competitive landscape report
TEV-48574 Dose Regiment B updates RSS · CI watch RSS
Teva Branded Pharmaceutical Products R&D LLC portfolio CI

Frequently asked questions about TEV-48574 Dose Regiment B

What is TEV-48574 Dose Regiment B?

TEV-48574 Dose Regiment B is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D LLC.

Who makes TEV-48574 Dose Regiment B?

TEV-48574 Dose Regiment B is developed by Teva Branded Pharmaceutical Products R&D LLC (see full Teva Branded Pharmaceutical Products R&D LLC pipeline at /company/teva-branded-pharmaceutical-products-r-d-llc).

Is TEV-48574 Dose Regiment B also known as anything else?

TEV-48574 Dose Regiment B is also known as duvakitug.

What development phase is TEV-48574 Dose Regiment B in?

TEV-48574 Dose Regiment B is in Phase 2.

Manufacturer: Teva Branded Pharmaceutical Products R&D LLC — full pipeline
Also known as: duvakitug

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