Tegsedi

(inotersen)

RNA therapy

AAkcea Therapeutics

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2030

Not yet recruiting

Pregnancy

NCT04270058

Clinical

Trials by Indication[1]

Polyneuropathy3 trials

Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 2/3·NCT01737398·173 enrolled

Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT02175004·135 enrolled

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT04136184·168 enrolled

Cardiomyopathy1 trial

24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients

Terminated·—·Phase 2·NCT03702829·31 enrolled

ESS1 trial

ATTR Expanded Access Program (EAP) by Ionis

Approved for marketing· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals··NCT03400098

Pregnancy1 trial

TEGSEDI Pregnancy Surveillance Program

Not yet recruiting·AAkcea Therapeutics··NCT04270058·20 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 5, 2018

TEGSEDI

NDA NDA211172

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for inotersen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — inotersen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211172). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Tegsedi. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Akcea Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Company: AAkcea Therapeutics

Patent Landscape[4]

Patent Cliff

Apr 29, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9399774Apr 29, 2031

9061044Apr 29, 2031

8697860Apr 29, 2031

Tegsedi

Expected Milestones

Q4 2030

Trials by Indication[1]

Polyneuropathy3 trials

Cardiomyopathy1 trial

ESS1 trial

Pregnancy1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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