Last reviewed 2026-04-19 · How we verify

Ziconotide [Prialt]

ESTEVE Pharmaceuticals SAS · Phase 2 active Small molecule

Ziconotide [Prialt] is a Small molecule drug developed by ESTEVE Pharmaceuticals SAS. It is currently in Phase 2 development.

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	Ziconotide [Prialt]
Sponsor	ESTEVE Pharmaceuticals SAS
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

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:

Ziconotide [Prialt] CI brief — competitive landscape report
Ziconotide [Prialt] updates RSS · CI watch RSS
ESTEVE Pharmaceuticals SAS portfolio CI

Frequently asked questions about Ziconotide [Prialt]

What is Ziconotide [Prialt]?

Ziconotide [Prialt] is a Small molecule drug developed by ESTEVE Pharmaceuticals SAS.

Who makes Ziconotide [Prialt]?

Ziconotide [Prialt] is developed by ESTEVE Pharmaceuticals SAS (see full ESTEVE Pharmaceuticals SAS pipeline at /company/esteve-pharmaceuticals-sas).

What development phase is Ziconotide [Prialt] in?

Ziconotide [Prialt] is in Phase 2.

Manufacturer: ESTEVE Pharmaceuticals SAS — full pipeline

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