Valchlor

(Mechlorethamine)

Phase 3Small molecule

RRECORDATI GROUP

Valchlor is one of 28 small molecule programs targeting Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

LymphomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Valchlor

RRECORDATI GROUP

Phase 3

1 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Zofran

Novartis

Preclinical

2 4

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 5

Emend

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

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

PEG-Intron

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

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

Clinical

Trials by Indication[1]

Lymphoma1 trial

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003389·854 enrolled

Treatment1 trial

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Completed·SSoligenix·Phase 2·NCT06149247·10 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MUSTARGEN

NDA NDA006695

Aug 23, 2013

VALCHLOR

NDA NDA202317

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Mechlorethamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mechlorethamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mechlorethamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202317). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Valchlor. U.S. Food & Drug Administration.
[6]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RRECORDATI GROUP

Patent Landscape[5]

Patent Cliff

Jul 8, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8501819Mar 7, 2026

8450375Mar 7, 2026

8501818Mar 7, 2026

7838564Mar 7, 2026

9382191Mar 7, 2026

1 more patents

7872050Jul 8, 2029

Valchlor

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Lymphoma1 trial

Treatment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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