Last reviewed 2026-05-22 · How we verify

TBI-223 SR Tablet Prototype 1

Global Alliance for TB Drug Development · Phase 1 active Small molecule ✓ Verified May 2026

TBI-223 SR Tablet Prototype 1 is a Small molecule drug developed by Global Alliance for TB Drug Development. It is currently in Phase 1 development.

TBI-223 SR Tablet Prototype 1 is a small molecule intervention being studied in a Phase 1 clinical trial for its safety, tolerability, and pharmacokinetics in healthy adults. The trial is focused on evaluating TBI-223 for the treatment of tuberculosis, specifically pulmonary tuberculosis.

Likelihood of approval

9.6% 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).

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	TBI-223 SR Tablet Prototype 1
Sponsor	Global Alliance for TB Drug Development
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults (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:

TBI-223 SR Tablet Prototype 1 CI brief — competitive landscape report
TBI-223 SR Tablet Prototype 1 updates RSS · CI watch RSS
Global Alliance for TB Drug Development portfolio CI

Frequently asked questions about TBI-223 SR Tablet Prototype 1

What is TBI-223 SR Tablet Prototype 1?

TBI-223 SR Tablet Prototype 1 is a Small molecule drug developed by Global Alliance for TB Drug Development.

Who makes TBI-223 SR Tablet Prototype 1?

TBI-223 SR Tablet Prototype 1 is developed by Global Alliance for TB Drug Development (see full Global Alliance for TB Drug Development pipeline at /company/global-alliance-for-tb-drug-development).

What development phase is TBI-223 SR Tablet Prototype 1 in?

TBI-223 SR Tablet Prototype 1 is in Phase 1.

Manufacturer: Global Alliance for TB Drug Development — full pipeline

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