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Vivia

(Nirogacestat)

ApprovedSmall molecule

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Nirogacestat is used to treat a rare genetic skin condition called epidermolysis bullosa simplex, where the skin is extremely fragile and blisters easily. It helps strengthen the skin by blocking a protein that breaks down skin cell connections.[2] Vivia is currently approved and in use across 9 indications[4].[1]

Vivia is one of 198 small molecule programs targeting Ovarian Granulosa Cell Tumor. It is currently in Approved.

9

Indications

20

Total Trials

16

Active Trials

197

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

29

Patents

Pipeline

Status by Indication[4][1]

Indication

Ovarian Granulosa Cell TumorActive, not recruiting

Alzheimer DiseaseApproved

Desmoid-Type FibromatosisActive, not recruiting

Breast NeoplasmApproved

FibromatosisActive, not recruiting

Breast CancerApproved

Multiple MyelomaActive, not recruiting

ObesityActive, not recruiting

Desmoid TumorRecruiting

Ovarian Granulosa Cell TumorPhase 2

Active, not recruiting

Alzheimer DiseaseApproved

Approved

Desmoid-Type FibromatosisApproved

Active, not recruiting

Breast NeoplasmApproved

Approved

FibromatosisPhase 2

Active, not recruiting

Breast CancerApproved

Approved

Multiple MyelomaPhase 2

Active, not recruiting

ObesityPhase 3

Active, not recruiting

Desmoid TumorApproved

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Halaven

Feraheme

AAzurity Pharmaceuticals

Aquasol E

NNational Eye Institute (NEI)

Vfend

PPrism Pharmaceuticals

Fentanyl Citrate

IINSYS Therapeutics Inc

Motexafin Gadolinium

PPharmacyclics LLC.

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Diuretic

RReprieve Cardiovascular, Inc

Lipegfilgrastim

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Multiple Myeloma

NCT05556798

Phase 1Recruiting

Adult

NCT07259330

Q1 2027

Phase 1/2Active, not recruiting

ART

NCT07084896

Phase 2Active, not recruiting

Multiple Myeloma

NCT04126200

Phase 1/2Active, not recruiting

Dexamethasone

NCT07150091

PreclinicalActive, not recruiting

Multiple Myeloma

NCT07150104

Clinical

Trials by Indication[1]

Multiple Myeloma7 trials

A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05556798·9 enrolled

A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma

Terminated·PPrecision BioSciences, Inc.·Phase 1·NCT04171843·48 enrolled

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Active, not recruiting· GSK logo

GSK·Phase 2·NCT04126200·208 enrolled

Show 4 more trials

Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

Active, not recruiting·AAllogene Therapeutics·Phase 1·NCT04093596·132 enrolled

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Recruiting· Regeneron logo

Regeneron·Phase 1·NCT05137054·317 enrolled

A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04722146·140 enrolled

A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 7 - Belantamab Mafodotin, Nirogacestat, Pomalidomide, and Dexamethasone in Combination

Active, not recruiting· GSK logo

GSK·Preclinical·NCT07150104·14 enrolled

Desmoid Tumor5 trials

Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05879146·40 enrolled

A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT04195399·35 enrolled

Study of Cryoablation and Nirogacestat for Desmoid Tumor

Recruiting·NNam Bui·Phase 2·NCT05949099·28 enrolled

Show 2 more trials

A Single-arm, Open-label Phase 2 Study of Nirogacestat in Adult Japanese Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Active, not recruiting·SSpringWorks Therapeutics, Inc.·Phase 2·NCT07170644·20 enrolled

A Single-Arm, Open-Label Phase 4 Study of Nirogacestat in Adult Premenopausal Females With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Recruiting·SSpringWorks Therapeutics, Inc.·Approved·NCT07176689·50 enrolled

ART1 trial

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM

Active, not recruiting· GSK logo

GSK·Phase 1/2·NCT07084896·106 enrolled

Adult1 trial

To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants

Recruiting·SSpringWorks Therapeutics, Inc.·Phase 1·NCT07259330·16 enrolled

MPA1 trial

Individual Patient Compassionate Use of Nirogacestat

Available·SSpringWorks Therapeutics, Inc.··NCT05041036

5 more indications

Fibromatosis1 trial

Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

Completed·SSpringWorks Therapeutics, Inc.·Phase 3·NCT03785964·142 enrolled

Dexamethasone1 trial

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM

Active, not recruiting· GSK logo

GSK·Phase 1/2·NCT07150091·20 enrolled

Ovarian Granulosa Cell Tumor1 trial

Nirogacestat in Ovarian Granulosa Cell Tumors

Completed·SSpringWorks Therapeutics, Inc.·Phase 2·NCT05348356·53 enrolled

Obesity1 trial

ANDES: Cagrilintide + Semaglutide in Obesity

Recruiting· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT05573802·3,000 enrolled

Unspecified1 trial

Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat

Recruiting·SSpringWorks Therapeutics, Inc.·Phase 1·NCT07171619·24 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 27, 2023

OGSIVEO

NDA NDA217677

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Nirogacestat. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vivia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nirogacestat compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nirogacestat. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217677). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Vivia. U.S. Food & Drug Administration.
[7]
SEC EDGAR — SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gamma-Secretase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Patent Landscape[6]

Patent Cliff

Aug 18, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7795447Aug 18, 2030

11820748Aug 9, 2039

10941118Aug 9, 2039

10710966Aug 9, 2039

11845732Aug 9, 2039

24 more patents

11884635Aug 9, 2039

10590087Aug 9, 2039

12297177Aug 9, 2039

11884634Aug 9, 2039

12116347Aug 9, 2039

11905255Aug 9, 2039

11612588Jul 8, 2042

12599587Jul 8, 2042

12247012Jul 8, 2042

11504354Jul 8, 2042

12110277Jul 8, 2042

12234210Jul 8, 2042

11807611Sep 8, 2042

11844780Sep 8, 2042

11872211May 19, 2043

12036207May 19, 2043

11951096May 19, 2043

11957662May 19, 2043

11938116May 19, 2043

11925619May 19, 2043

11925620May 19, 2043

12011434May 19, 2043

12011435May 19, 2043

12138246May 19, 2043

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