Savella

(Milnacipran)

ApprovedSmall molecule

Savella is a small molecule that works as a Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Savella is one of 329 small molecule programs targeting Peripheral Neuropathy. It is currently in Approved.

Indications

Total Trials

Active Trials

328

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Peripheral NeuropathyApproved

Neuropathic PainApproved

Depressive DisorderActive, not recruiting

Major Depressive DisorderActive, not recruiting

StrokeActive, not recruiting

Shoulder PainActive, not recruiting

FibromyalgiaCompleted

Rheumatoid ArthritisCompleted

OsteoarthritisUnknown status

AutismCompleted

Peripheral NeuropathyApproved

Approved

Neuropathic PainApproved

Approved

Depressive DisorderApproved

Active, not recruiting

Major Depressive DisorderApproved

Active, not recruiting

StrokePreclinical

Active, not recruiting

Shoulder PainApproved

Active, not recruiting

FibromyalgiaApproved

Completed

Rheumatoid ArthritisApproved

Completed

OsteoarthritisApproved

Unknown status

AutismApproved

Completed

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Savella

AbbVie

Approved

2 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

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

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Disalcid

JJoslin Diabetes Center

Preclinical

—

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

Clinical

Trials by Indication[1]

Fibromyalgia15 trials

Effect of Milnacipran / Gabapentin in Fibromyalgia

Unknown status·MMansoura University·N/A·NCT05384210·75 enrolled

Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

Completed·FForest Laboratories·Phase 4·NCT01014585·340 enrolled

Study of Milnacipran for the Treatment of Fibromyalgia

Completed·FForest Laboratories·Phase 3·NCT00314249·1,025 enrolled

Show 12 more trials

Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

Terminated·FForest Laboratories·Phase 3·NCT00793520·2 enrolled

Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients

Completed·UUniversity of Florida·Phase 1·NCT01294059·51 enrolled

Prospective Study of the Influence of the Diffuse Noxious Inhibitory Controls of the Pain on the Efficacy of Milnacipran in Fibromyalgia Therapy

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT01747044·48 enrolled

Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial

Completed·—·Phase 3·NCT01829243·26 enrolled

A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Completed·PPierre Fabre Medicament·Phase 3·NCT00436033·1,429 enrolled

A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia

Completed·UUniversity of Michigan·Phase 4·NCT01173055·22 enrolled

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Completed·FForest Laboratories·Phase 4·NCT01077375·107 enrolled

Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Terminated·FForest Laboratories·Phase 2·NCT01331109·57 enrolled

The Effect of Milnacipran in Patients With Fibromyalgia

Completed·—·Phase 2/3·NCT01108731·37 enrolled

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Completed·—·Phase 4·NCT01234675·19 enrolled

Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Terminated·FForest Laboratories·Phase 2·NCT01328002·116 enrolled

Study of Fibromyalgia Treated With Milnacipran

Completed·—·Phase 4·NCT01125423·27 enrolled

Migraine2 trials

Study Evaluated the Effectiveness of Milnacipran to Reduce Pain Levels in Individuals With Chronic Migraine

Completed·TTimothy Smith·N/A·NCT01393522·37 enrolled

Preventive Treatment of Episodic and Chronic Migraine

Unknown status·CCalifornia Medical Clinic for Headache·Phase 4·NCT01319825·45 enrolled

Osteoarthritis2 trials

Milnacipran for Chronic Pain in Knee Osteoarthritis

Completed·—·Phase 4·NCT01510457·46 enrolled

Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis

Unknown status·AAnalgesic Solutions·Phase 4·NCT01329406·50 enrolled

Rheumatoid Arthritis2 trials

Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis

Completed·UUniversity of California, Los Angeles·Phase 4·NCT01225991·18 enrolled

Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis

Completed·—·Phase 4·NCT01207453·49 enrolled

Shoulder pain1 trial

"MILNACIPRAN" in Subjects With Chronic Shoulder Pain

Completed·VValera Bussell·Phase 4·NCT01289236·40 enrolled

13 more indications

Neuropathy1 trial

A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain

Terminated·—·Phase 3·NCT01288937·6 enrolled

Analgesic1 trial

Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Completed·PPierre Fabre Medicament·Phase 2·NCT00757679·153 enrolled

Autism1 trial

Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism

Completed·MMontefiore Medical Center·Phase 4·NCT01337700·10 enrolled

Lumbosacral Radicular Pain1 trial

Milnacipran for Lumbosacral Radicular Pain

Completed·—·Phase 4·NCT01777581·13 enrolled

Sciatica1 trial

Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica

Unknown status·RRambam Health Care Campus·Phase 2·NCT01914042·150 enrolled

Low back pain1 trial

Effect of Milnacipran in Chronic Neuropathic Low Back Pain

Completed·NNorthwestern University·Phase 2·NCT01225068·40 enrolled

Stroke1 trial

Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?

Unknown status·—·N/A·NCT00606203·120 enrolled

Treatment1 trial

Savella in Treatment for Provoked Vestibulodynia

Completed·UUniversity of Tennessee·Phase 3·NCT01304589·31 enrolled

Irritable Bowel Syndrome1 trial

Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

Terminated·SSpencer Dorn, MD, MPH·Phase 2·NCT01471379·2 enrolled

Major Depression1 trial

Study Evaluating Effexor XR for Major Depression.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00225511·590 enrolled

Fatigue1 trial

The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients

Withdrawn·LLoma Linda University·Phase 4·NCT01359826

Progressive Disease1 trial

Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease

Completed·UUniversity Hospital, Lille·Phase 2/3·NCT02783430·42 enrolled

Unspecified1 trial

FMS European Long-Term Study

Completed·PPierre Fabre Medicament·Phase 3·NCT00757731·490 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 14, 2009

SAVELLA

NDA NDA022256

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Milnacipran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Milnacipran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Milnacipran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022256). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Savella. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Sep 19, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7994220Sep 19, 2029

Savella

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Fibromyalgia15 trials

Migraine2 trials

Osteoarthritis2 trials

Rheumatoid Arthritis2 trials

Shoulder pain1 trial

Neuropathy1 trial

Analgesic1 trial

Autism1 trial

Lumbosacral Radicular Pain1 trial

Sciatica1 trial

Low back pain1 trial

Stroke1 trial

Treatment1 trial

Irritable Bowel Syndrome1 trial

Major Depression1 trial

Fatigue1 trial

Progressive Disease1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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