HL-085

Phase 2Small molecule

SShanghai Kechow Pharma, Inc.

HL-085 is one of 14 small molecule programs targeting Neurofibromatosis Type 1. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Neurofibromatosis Type 1Recruiting

Neurofibromatosis Type 1Phase 2

Recruiting

Competition

Competitive Landscape

15 competitors in Neurofibromatosis Type 1

#DrugCompanyPhaseTrials

Ritalin

Novartis

Approved

1 2

Verzenio

Eli Lilly

Approved

—3

Levulan

Sun Pharmaceutical Industries, Inc.

Afinitor

Lamictal

GGlaxo Dba Glaxosmithkline

Approved

—6

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

—7

Celebrex

PPhiladelphia Eye Associates

Approved

—8

Acetadote

AArbor Pharmaceuticals, Inc.

Koselugo

2 10

N-Acetyl Cyteien

SStanford University

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 2Recruiting

Neurofibromatosis Type 1

NCT05331105

Clinical

Trials by Indication[1]

Melanoma3 trials

HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation

Unknown status·SShanghai Kechow Pharma, Inc.·Phase 2·NCT05263453·104 enrolled

HL-085 in NRAS-mutated Advanced Melanoma

Completed·SShanghai Kechow Pharma, Inc.·Phase 2·NCT05217303·100 enrolled

Study of HL-085 in NRAS Mutant Advanced Melanoma

Completed·SShanghai Kechow Pharma, Inc.·Phase 1/2·NCT03973151·42 enrolled

Metastatic Colorectal Cancer1 trial

Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)

Unknown status·SShanghai Kechow Pharma, Inc.·Phase 2·NCT05233332·186 enrolled

Advanced Solid Tumor1 trial

Study of HL-085 in Patients With Advanced Solid Tumor Tumors

Completed·KKechow Pharma, Inc.·Phase 1·NCT04683354·28 enrolled

NSCLC1 trial

Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC

Terminated·SShanghai Kechow Pharma, Inc.·Phase 1·NCT03990077·2 enrolled

Neurofibromatosis Type 11 trial

HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas

Recruiting·SShanghai Kechow Pharma, Inc.·Phase 2·NCT05331105·70 enrolled

2 more indications

BRAF V600 Mutation1 trial

A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Unknown status·SShanghai Kechow Pharma, Inc.·Phase 1·NCT03781219·45 enrolled

Patients With Advanced Solid Tumors1 trial

Phase I Study of HL-085 in Patients With Advanced Solid Tumors

Terminated·SShanghai Kechow Pharma, Inc.·Phase 1·NCT03976050·4 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for HL-085. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HL-085 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HL-085. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shanghai Kechow Pharma, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: SShanghai Kechow Pharma, Inc.

HL-085

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Melanoma3 trials

Metastatic Colorectal Cancer1 trial

Advanced Solid Tumor1 trial

NSCLC1 trial

Neurofibromatosis Type 11 trial

BRAF V600 Mutation1 trial

Patients With Advanced Solid Tumors1 trial

References

Drug Info

Quick Facts

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