Last reviewed 2026-05-30 · How we verify

Encorafenib Pill (encorafenib-pill)

Pfizer Inc. · Phase 1 active ✓ Verified May 2026 Quality 10/100

Encorafenib Pill (generic name: encorafenib-pill) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.

Encorafenib is a small molecule pill used to treat melanoma, specifically in cases with the BRAF V600 mutation, at stages III and IV. It is often combined with other treatments, such as Binimetinib and Nivolumab, as part of clinical trials to evaluate its effectiveness.

Likelihood of approval

12.6% 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).
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	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	encorafenib-pill
Sponsor	Pfizer Inc.
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Fatigue
Pyrexia
Nausea
Vomiting
Abdominal pain
Arthralgia
Hyperkeratosis
Rash
Constipation
Headache
Dizziness
Peripheral neuropathy

Key clinical trials

Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma (EARLY_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:

Encorafenib Pill CI brief — competitive landscape report
Encorafenib Pill updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about Encorafenib Pill

What is Encorafenib Pill?

Encorafenib Pill (encorafenib-pill) is a pharmaceutical drug developed by Pfizer Inc..

Who makes Encorafenib Pill?

Encorafenib Pill is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Encorafenib Pill?

encorafenib-pill is the generic (nonproprietary) name of Encorafenib Pill.

What development phase is Encorafenib Pill in?

Encorafenib Pill is in Phase 1.

What are the side effects of Encorafenib Pill?

Common side effects of Encorafenib Pill include Fatigue, Pyrexia, Nausea, Vomiting, Abdominal pain, Arthralgia.

Manufacturer: Pfizer Inc. — full pipeline

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