Last reviewed 2026-05-31 · How we verify

Tapentadol Prolonged-release Reference Product

Grünenthal GmbH · Phase 1 active Small molecule ✓ Verified May 2026

Tapentadol Prolonged-release Reference Product is a Small molecule drug developed by Grünenthal GmbH. It is currently in Phase 1 development.

Tapentadol Prolonged-release Reference Product is a small molecule used in pharmacokinetic studies. It is a prolonged-release formulation of the compound CG5503, which is also known as Tapentadol.

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	Tapentadol Prolonged-release Reference Product
Sponsor	Grünenthal GmbH
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers (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:

Tapentadol Prolonged-release Reference Product CI brief — competitive landscape report
Tapentadol Prolonged-release Reference Product updates RSS · CI watch RSS
Grünenthal GmbH portfolio CI

Frequently asked questions about Tapentadol Prolonged-release Reference Product

What is Tapentadol Prolonged-release Reference Product?

Tapentadol Prolonged-release Reference Product is a Small molecule drug developed by Grünenthal GmbH.

Who makes Tapentadol Prolonged-release Reference Product?

Tapentadol Prolonged-release Reference Product is developed by Grünenthal GmbH (see full Grünenthal GmbH pipeline at /company/gr-nenthal-gmbh).

What development phase is Tapentadol Prolonged-release Reference Product in?

Tapentadol Prolonged-release Reference Product is in Phase 1.

Manufacturer: Grünenthal GmbH — full pipeline

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