Last reviewed 2026-05-30 · How we verify

non-TNFi-biologic class

University of Alabama at Birmingham · Phase 3 active Small molecule ✓ Verified May 2026 Quality 10/100

non-TNFi-biologic class is a Non-TNF inhibitor biologic Small molecule drug developed by University of Alabama at Birmingham. It is currently in Phase 3 development.

Non-TNFi-biologic class refers to a type of medication used to treat Rheumatoid Arthritis, which is a targeted synthetic DMARD. This class of medication is being studied in real-world settings, such as in the RA-PRO PRAGMATIC TRIAL, to evaluate its effectiveness in treating the condition.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	non-TNFi-biologic class
Sponsor	University of Alabama at Birmingham
Drug class	Non-TNF inhibitor biologic
Modality	Small molecule
Phase	Phase 3

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

RA-PRO PRAGMATIC TRIAL (PHASE3)

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:

non-TNFi-biologic class CI brief — competitive landscape report
non-TNFi-biologic class updates RSS · CI watch RSS
University of Alabama at Birmingham portfolio CI

Frequently asked questions about non-TNFi-biologic class

What is non-TNFi-biologic class?

non-TNFi-biologic class is a Non-TNF inhibitor biologic drug developed by University of Alabama at Birmingham.

Who makes non-TNFi-biologic class?

non-TNFi-biologic class is developed by University of Alabama at Birmingham (see full University of Alabama at Birmingham pipeline at /company/university-of-alabama-at-birmingham).

What drug class is non-TNFi-biologic class in?

non-TNFi-biologic class belongs to the Non-TNF inhibitor biologic class. See all Non-TNF inhibitor biologic drugs at /class/non-tnf-inhibitor-biologic.

What development phase is non-TNFi-biologic class in?

non-TNFi-biologic class is in Phase 3.

Drug class: All Non-TNF inhibitor biologic drugs
Manufacturer: University of Alabama at Birmingham — full pipeline

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