Last reviewed 2026-04-20 · How we verify

Calmatel (PIKETOPROFEN)

Phase 2 active Small molecule

Calmatel (generic name: PIKETOPROFEN) is a drug. It is currently in Phase 2 development for Pain.

Calmatel (PIKETOPROFEN) is a small molecule drug that targets Prostaglandin G/H synthase 1, a key enzyme involved in pain signaling. It belongs to the piketoprofen class and is used to treat pain. The commercial status of Calmatel is currently unknown, and it has not been approved by the FDA. As a result, its availability, safety profile, and efficacy are not well established. Further research is needed to fully understand the properties and potential of Calmatel.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	PIKETOPROFEN
Target	Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Approved indications

Pain

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Calmatel CI brief — competitive landscape report
Calmatel updates RSS · CI watch RSS

Frequently asked questions about Calmatel

What is Calmatel?

Calmatel (PIKETOPROFEN) is a Small molecule drug, indicated for Pain.

What is Calmatel used for?

Calmatel is indicated for Pain.

What is the generic name of Calmatel?

PIKETOPROFEN is the generic (nonproprietary) name of Calmatel.

What development phase is Calmatel in?

Calmatel is in Phase 2.

What does Calmatel target?

Calmatel targets Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2.

Target: All drugs targeting Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2
Therapeutic area: All drugs in Pain
Indication: Drugs for Pain

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