Norflex

(orphenadrine)

ApprovedSmall molecule

33M

Norflex is one of 58 small molecule programs targeting Spinal Fusion. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Spinal FusionActive, not recruiting

Muscle CrampActive, not recruiting

Spinal FusionApproved

Active, not recruiting

Muscle CrampPhase 3

Active, not recruiting

Competition

Competitive Landscape

48 competitors in Spinal Fusion

#DrugCompanyPhaseTrials

Medrol

Pfizer

Approved

1 2

MS Contin

HHikma Pharmaceuticals LLC

Approved

4 3

Decadron

AAspen Global Incorporated

Approved

2 4

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 5

Marcaine

IInnocoll

Approved

2 6

Toradol

JJavelin Pharmaceuticals

Approved

2 7

Vancocin

HHikma Pharmaceuticals LLC

Approved

2 8

Vivarin

HHikma Pharmaceuticals LLC

Approved

1 9

Duragesic

CCephalon

Approved

1 10

Dilaudid

RRhodes Pharmaceuticals, L.P.

Approved

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

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

Muscle Cramp

NCT02423395

Clinical

Trials by Indication[1]

Muscle Cramp2 trials

Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT02423395·100 enrolled

Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Terminated·MMansoura University·N/A·NCT04509336·5 enrolled

Completed·UUniversity of Puerto Rico·Phase 4·NCT05413902·100 enrolled

CAR1 trial

Orphenadrine and Methocarbamol for LBP

Completed·MMontefiore Medical Center·Phase 4·NCT02665286·240 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

NORFLEX

NDA NDA013055

Jan 1, 1982

NORFLEX

NDA NDA012157

Jan 1, 1982

DISIPAL

NDA NDA010653

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for orphenadrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — orphenadrine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for orphenadrine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA013055). U.S. Food & Drug Administration.
[5]
SEC EDGAR — 3M company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: 33M

Norflex

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Muscle Cramp2 trials

Patient Preference1 trial

Perioperative Pain Control1 trial

Spinal Fusion1 trial

CAR1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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