Last reviewed 2026-05-22 · How we verify

Nimesulide + Pantoprazole

EMS · Phase 3 active Small molecule ✓ Verified May 2026

Nimesulide + Pantoprazole is a NSAID + Proton pump inhibitor combination Small molecule drug developed by EMS. It is currently in Phase 3 development for Acute pain and inflammation with gastric protection, Musculoskeletal pain conditions requiring NSAID therapy with reduced GI risk.

Nimesulide inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while pantoprazole suppresses gastric acid production to protect the stomach lining.

Nimesulide, a small molecule, and Pantoprazole have been studied together for the treatment of acute and chronic inflammation, as well as dyspepsia, in clinical trials. The combination of Nimesulide and Pantoprazole has been evaluated for safety in a parallel, double-blind, randomized study for the treatment of osteoarticular inflammation in dyspeptic patients.

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	Nimesulide + Pantoprazole
Sponsor	EMS
Drug class	NSAID + Proton pump inhibitor combination
Target	COX-2 enzyme (nimesulide); H+/K+-ATPase (pantoprazole)
Modality	Small molecule
Therapeutic area	Gastroenterology / Pain Management
Phase	Phase 3

Mechanism of action

This is a fixed-dose combination where nimesulide, a selective COX-2 inhibitor NSAID, provides anti-inflammatory and analgesic effects by blocking prostaglandin synthesis. Pantoprazole, a proton pump inhibitor, reduces gastric acid secretion to mitigate NSAID-induced gastrointestinal toxicity and ulceration risk. The combination allows therapeutic NSAID dosing with reduced GI adverse effects.

Approved indications

Acute pain and inflammation with gastric protection
Musculoskeletal pain conditions requiring NSAID therapy with reduced GI risk

Common side effects

Headache
Dizziness
Gastrointestinal disturbance
Nausea
Abdominal pain

Key clinical trials

Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients (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:

Nimesulide + Pantoprazole CI brief — competitive landscape report
Nimesulide + Pantoprazole updates RSS · CI watch RSS
EMS portfolio CI

Frequently asked questions about Nimesulide + Pantoprazole

What is Nimesulide + Pantoprazole?

Nimesulide + Pantoprazole is a NSAID + Proton pump inhibitor combination drug developed by EMS, indicated for Acute pain and inflammation with gastric protection, Musculoskeletal pain conditions requiring NSAID therapy with reduced GI risk.

How does Nimesulide + Pantoprazole work?

Nimesulide inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while pantoprazole suppresses gastric acid production to protect the stomach lining.

What is Nimesulide + Pantoprazole used for?

Nimesulide + Pantoprazole is indicated for Acute pain and inflammation with gastric protection, Musculoskeletal pain conditions requiring NSAID therapy with reduced GI risk.

Who makes Nimesulide + Pantoprazole?

Nimesulide + Pantoprazole is developed by EMS (see full EMS pipeline at /company/ems).

What drug class is Nimesulide + Pantoprazole in?

Nimesulide + Pantoprazole belongs to the NSAID + Proton pump inhibitor combination class. See all NSAID + Proton pump inhibitor combination drugs at /class/nsaid-proton-pump-inhibitor-combination.

What development phase is Nimesulide + Pantoprazole in?

Nimesulide + Pantoprazole is in Phase 3.

What are the side effects of Nimesulide + Pantoprazole?

Common side effects of Nimesulide + Pantoprazole include Headache, Dizziness, Gastrointestinal disturbance, Nausea, Abdominal pain.

What does Nimesulide + Pantoprazole target?

Nimesulide + Pantoprazole targets COX-2 enzyme (nimesulide); H+/K+-ATPase (pantoprazole) and is a NSAID + Proton pump inhibitor combination.

Drug class: All NSAID + Proton pump inhibitor combination drugs
Target: All drugs targeting COX-2 enzyme (nimesulide); H+/K+-ATPase (pantoprazole)
Manufacturer: EMS — full pipeline
Therapeutic area: All drugs in Gastroenterology / Pain Management
Indication: Drugs for Acute pain and inflammation with gastric protection
Indication: Drugs for Musculoskeletal pain conditions requiring NSAID therapy with reduced GI risk

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