Last reviewed 2026-05-20 · How we verify

Lorviqua (lorviqua)

Pfizer Inc. · preclinical active Under review Quality 0/100

Lorviqua (generic name: lorviqua) is a As provided in real world practice drug developed by Pfizer Inc.. It is currently in preclinical development for ALK fusion gene-positive non-small-cell lung cancer, Non-small cell lung cancer.

As provided in real world practice

Lorviqua is an orally administered small molecule inhibitor of the ALK tyrosine kinase receptor. It is used to treat non-small cell lung cancer (NSCLC) and is administered in a 100 mg dose.

Likelihood of approval

8% vs 5% industry baseline

If approved by FDA: likely 2036–2040

Steps remaining: Phase 1 → Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Low

Why this estimate

Baseline preclinical → approval rate +5.0pp
Industry-wide preclinical drugs reach approval ~5% 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	2036–2040	—
EMA	EU	2037–2041	+0.7 yr
MHRA	GB	2037–2041	+0.7 yr
Health Canada	CA	2037–2042	+0.9 yr
TGA	AU	2037–2042	+1.2 yr
PMDA	JP	2037–2042	+1.5 yr
NMPA	CN	2038–2043	+2.3 yr
MFDS	KR	2037–2042	+1.4 yr
CDSCO	IN	2037–2043	+1.8 yr
ANVISA	BR	2038–2043	+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	lorviqua
Sponsor	Pfizer Inc.
Drug class	As provided in real world practice
Target	Tyrosine-protein kinase FRK, ALK tyrosine kinase receptor, Activated CDC42 kinase 1
Therapeutic area	Oncology
Phase	preclinical

Mechanism of action

Some lung cancers have a genetic abnormality where two genes fuse together to create an overactive ALK protein. This abnormal protein sends constant growth signals that cause cancer cells to multiply uncontrollably. Lorviqua is a targeted drug that blocks this faulty ALK protein, essentially turning off the cancer's growth engine. What makes Lorviqua special is its ability to reach cancer cells in the brain. Many cancer drugs are too large or the wrong chemical shape to cross from the bloodstream into brain tissue, so brain tumors continue growing even when the drug controls cancer elsewhere in the body. Lorviqua's unique design allows it to penetrate this protective barrier and kill cancer cells hiding in the brain. Additionally, some patients initially respond well to earlier ALK-blocking drugs but eventually develop resistance when the cancer mutates to avoid the drug's effects. Lorviqua is designed to overcome many of these resistance mutations, making it effective even after previous ALK inhibitor treatments have stopped working.

Approved indications

ALK fusion gene-positive non-small-cell lung cancer
Non-small cell lung cancer

Pipeline indications

Metastatic ALK+ Non Small Cell Lung Cancer — preclinical

Common side effects

No common side effects on file.

Key clinical trials

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:

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

Frequently asked questions about Lorviqua

What is Lorviqua?

Lorviqua (lorviqua) is a As provided in real world practice drug developed by Pfizer Inc., indicated for ALK fusion gene-positive non-small-cell lung cancer, Non-small cell lung cancer.

How does Lorviqua work?

As provided in real world practice

What is Lorviqua used for?

Lorviqua is indicated for ALK fusion gene-positive non-small-cell lung cancer, Non-small cell lung cancer.

Who makes Lorviqua?

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

What is the generic name of Lorviqua?

lorviqua is the generic (nonproprietary) name of Lorviqua.

What drug class is Lorviqua in?

Lorviqua belongs to the As provided in real world practice class. See all As provided in real world practice drugs at /class/as-provided-in-real-world-practice.

What development phase is Lorviqua in?

Lorviqua is in preclinical.

What does Lorviqua target?

Lorviqua targets Tyrosine-protein kinase FRK, ALK tyrosine kinase receptor, Activated CDC42 kinase 1 and is a As provided in real world practice.

Drug class: All As provided in real world practice drugs
Target: All drugs targeting Tyrosine-protein kinase FRK, ALK tyrosine kinase receptor, Activated CDC42 kinase 1
Manufacturer: Pfizer Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for ALK fusion gene-positive non-small-cell lung cancer
Indication: Drugs for Non-small cell lung cancer

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