Varubi

(Rolapitant)

Small molecule

TTerSera Therapeutics LLC

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Chemotherapy4 trials

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01500213·555 enrolled

Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Withdrawn·CCostantine Albany·Phase 2·NCT03960151

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01499849·532 enrolled

Show 1 more trial

Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01500226·1,369 enrolled

Single Dose1 trial

An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects

Completed·TTesaro, Inc.·Phase 1·NCT02434861·102 enrolled

Single Ascending Dose1 trial

A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers

Completed·TTesaro, Inc.·Phase 1·NCT02382666·100 enrolled

Intravenous1 trial

An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

Completed·TTesaro, Inc.·Phase 1·NCT02285647·138 enrolled

Malignant Glioma1 trial

Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide

Completed·—·Phase 2·NCT02991456·48 enrolled

Regulatory

FDA Approval Timeline[3]

Sep 1, 2015

VARUBI

NDA NDA206500

Oct 25, 2017

VARUBI

NDA NDA208399

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Rolapitant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rolapitant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208399). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Varubi. U.S. Food & Drug Administration.
[5]
SEC EDGAR — TerSera Therapeutics LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: TTerSera Therapeutics LLC

Patent Landscape[4]

Patent Cliff

Apr 4, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7563801Apr 4, 2027

8404702Apr 4, 2027

8178550Apr 4, 2027

7981905Apr 4, 2027

7049320Aug 19, 2028

3 more patents

8470842Jan 18, 2029

8361500Oct 9, 2029

9101615Jul 14, 2032