Who are ARQ 501's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Lorbrena, Lorbrena, Alunbrig, Alecensa, Tagrisso, CERITINIB.

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Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

ARQ 501 — Competitive Intelligence Brief

ARQ 501 (ARQ 501) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: ALK inhibitor. Area: Oncology.

phase 2 ALK inhibitor ALK Oncology Small molecule Live · refreshed every 30 min

Target snapshot

ARQ 501 (ARQ 501) — ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). ARQ 501 is a selective inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ARQ 501 TARGET	ARQ 501	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	phase 2	ALK inhibitor	ALK
Lorbrena	lorlatinib	Pfizer	marketed	Kinase Inhibitor [EPC]	ALK tyrosine kinase receptor	2018-01-01
Lorbrena	Lorlatinib	Pfizer	marketed	Kinase Inhibitor [EPC]	ALK tyrosine kinase receptor	2018-01-01
Alunbrig	brigatinib	Takeda	marketed	Kinase Inhibitor [EPC]	ALK tyrosine kinase receptor	2017-01-01
Alecensa	alectinib	Hoffmann-La Roche	marketed	Kinase Inhibitor	ALK tyrosine kinase receptor	2015-01-01
Tagrisso	osimertinib	AstraZeneca	marketed	Kinase Inhibitor [EPC]	ALK tyrosine kinase receptor	2015-01-01
CERITINIB	CERITINIB		marketed	Kinase Inhibitor [EPC]	ALK, IGF-1R, InsR, ROS1	2014-01-01

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

2032-07-25 — Tagrisso · 9732058 · US
2032-07-25 — Tagrisso · 11524951 · US
2032-08-08 — Tagrisso · 8946235 · US
2035-01-02 — Tagrisso · 10183020 · US

Sponsor landscape (ALK inhibitor class)

ALK-Abelló A/S · 2 drugs in this class
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · 1 drug in this class
Astellas Pharma Global Development, Inc. · 1 drug in this class
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · 1 drug in this class
Nuvalent Inc. · 1 drug in this class
Pfizer · 1 drug in this class
Takeda · 1 drug in this class

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Cite this brief

Drug Landscape (2026). ARQ 501 — Competitive Intelligence Brief. https://druglandscape.com/ci/arq-501. Accessed 2026-05-13.

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