Last reviewed 2026-05-22 · How we verify

Secretol

Effexus Pharmaceutical · Phase 1 active Small molecule ✓ Verified May 2026

Secretol is a Small molecule drug developed by Effexus Pharmaceutical. It is currently in Phase 1 development. Also known as: lansoprazole/omeprazole combination.

Secretol is a medication used to treat conditions such as Gastroesophageal Reflux Disease (GERD), heartburn, and indigestion. It has been compared to Nexium in clinical trials for its effectiveness in healing and controlling symptoms in GERD patients with severe esophageal erosion.

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	Secretol
Also known as	lansoprazole/omeprazole combination
Sponsor	Effexus Pharmaceutical
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE. (PHASE1, 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:

Secretol CI brief — competitive landscape report
Secretol updates RSS · CI watch RSS
Effexus Pharmaceutical portfolio CI

Frequently asked questions about Secretol

What is Secretol?

Secretol is a Small molecule drug developed by Effexus Pharmaceutical.

Who makes Secretol?

Secretol is developed by Effexus Pharmaceutical (see full Effexus Pharmaceutical pipeline at /company/effexus-pharmaceutical).

Is Secretol also known as anything else?

Secretol is also known as lansoprazole/omeprazole combination.

What development phase is Secretol in?

Secretol is in Phase 1.

Manufacturer: Effexus Pharmaceutical — full pipeline
Therapeutic area: All drugs in Other
Also known as: lansoprazole/omeprazole combination

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