Last reviewed 2026-05-31 · How we verify

AD-2141

Addpharma Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

AD-2141 is a Small molecule drug developed by Addpharma Inc.. It is currently in Phase 1 development. Also known as: Reference Drug.

AD-2141 is a small molecule being studied in a clinical trial for its safety, pharmacokinetics, and pharmacodynamics in comparison to AD-214 in healthy volunteers. The trial is focused on Gastroesophageal Reflux Disease, with AD-2141 being compared to AD-214 in a randomized, open-label, multiple-dose, crossover study.

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	AD-2141
Also known as	Reference Drug
Sponsor	Addpharma Inc.
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 Study to Compare PK, PD and Safety of the AD-214 and AD-2141 (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:

AD-2141 CI brief — competitive landscape report
AD-2141 updates RSS · CI watch RSS
Addpharma Inc. portfolio CI

Frequently asked questions about AD-2141

What is AD-2141?

AD-2141 is a Small molecule drug developed by Addpharma Inc..

Who makes AD-2141?

AD-2141 is developed by Addpharma Inc. (see full Addpharma Inc. pipeline at /company/addpharma-inc).

Is AD-2141 also known as anything else?

AD-2141 is also known as Reference Drug.

What development phase is AD-2141 in?

AD-2141 is in Phase 1.

Manufacturer: Addpharma Inc. — full pipeline
Also known as: Reference Drug

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