Last reviewed 2026-05-19 · How we verify

Palbociclib 125Mg Tab (palbociclib-125mg-tab)

Pfizer Inc. · Phase 2 active ✓ Verified May 2026 Quality 0/100

Palbociclib 125Mg Tab (generic name: palbociclib-125mg-tab) is a drug developed by Pfizer Inc.. It is currently in Phase 2 development.

Palbociclib 125mg is a small molecule used in the treatment of breast cancer, specifically hormone receptor-positive tumors that are human epidermal growth factor 2 negative. It is typically administered in combination with other treatments, such as letrozole, for the management of metastatic breast cancer.

Likelihood of approval

18.3% 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).
Big-pharma sponsor +3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	palbociclib-125mg-tab
Sponsor	Pfizer Inc.
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:

Palbociclib 125Mg Tab CI brief — competitive landscape report
Palbociclib 125Mg Tab updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about Palbociclib 125Mg Tab

What is Palbociclib 125Mg Tab?

Palbociclib 125Mg Tab (palbociclib-125mg-tab) is a pharmaceutical drug developed by Pfizer Inc..

Who makes Palbociclib 125Mg Tab?

Palbociclib 125Mg Tab is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Palbociclib 125Mg Tab?

palbociclib-125mg-tab is the generic (nonproprietary) name of Palbociclib 125Mg Tab.

What development phase is Palbociclib 125Mg Tab in?

Palbociclib 125Mg Tab is in Phase 2.

Manufacturer: Pfizer Inc. — full pipeline

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