Skip to main content

PIK3CA-Related Overgrowth Spectrum (PROS)

6
Pipeline Programs
5
Companies
3
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
6
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 4 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
5 programs
3
AlpelisibPhase 2Small Molecule
AlpelisibPhase 2Small Molecule
AlpelisibPhase 2Small Molecule
alpelisibN/ASmall Molecule
alpelisibN/ASmall Molecule
Relay Therapeutics
Relay TherapeuticsMA - Cambridge
1 program
1
RLY-2608Phase 21 trial
Active Trials
NCT06789913Recruiting277Est. Oct 2031
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
SirolimusPhase 21 trial
Active Trials
NCT02428296Completed39Est. Feb 2018
Genome & Company
Genome & CompanyKorea - Suwon
1 program
1
SirolimusPhase 2
HaiHe Biopharma
HaiHe BiopharmaChina - Shanghai
1 program
CYH33PHASE_1_21 trial
Active Trials
NCT06975618Recruiting141Est. Dec 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Relay TherapeuticsRLY-2608
Human BioSciencesSirolimus
HaiHe BiopharmaCYH33

Clinical Trials (3)

Total enrollment: 457 patients across 3 trials

A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)

Start: Jun 2025Est. completion: Oct 2031277 patients
Phase 2Recruiting

Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation

Start: Apr 2015Est. completion: Feb 201839 patients
Phase 2Completed

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Patients With PIK3CA-related Overgrowth Spectrum (PROS) and PIK3CA-related Vascular Malformations (PRVM)

Start: Aug 2023Est. completion: Dec 2029141 patients
Phase 1/2Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 actively recruiting trials targeting 457 patients
Small Molecule is the dominant modality (100% of programs)
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.