Last reviewed 2026-05-31 · How we verify

TMC278; Omeprazole

Tibotec Pharmaceuticals, Ireland · Phase 1 active Small molecule ✓ Verified May 2026

TMC278; Omeprazole is a Small molecule drug developed by Tibotec Pharmaceuticals, Ireland. It is currently in Phase 1 development.

TMC278 is a small molecule inhibitor of the potassium-transporting ATPase, and it was studied in a clinical trial for the treatment of HIV infections. Omeprazole, a potassium-transporting ATPase inhibitor with the same mechanism as TMC278, was used in the trial to evaluate its potential influence on the blood levels of TMC278 in healthy volunteers.

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	TMC278; Omeprazole
Sponsor	Tibotec Pharmaceuticals, Ireland
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase in the Stomach Triggered by Omeprazole Intake - on the Blood Levels of TMC278 in Healthy Volunteers (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:

TMC278; Omeprazole CI brief — competitive landscape report
TMC278; Omeprazole updates RSS · CI watch RSS
Tibotec Pharmaceuticals, Ireland portfolio CI

Frequently asked questions about TMC278; Omeprazole

What is TMC278; Omeprazole?

TMC278; Omeprazole is a Small molecule drug developed by Tibotec Pharmaceuticals, Ireland.

Who makes TMC278; Omeprazole?

TMC278; Omeprazole is developed by Tibotec Pharmaceuticals, Ireland (see full Tibotec Pharmaceuticals, Ireland pipeline at /company/tibotec-pharmaceuticals-ireland).

What development phase is TMC278; Omeprazole in?

TMC278; Omeprazole is in Phase 1.

Manufacturer: Tibotec Pharmaceuticals, Ireland — full pipeline

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