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PORT-77

Phase 2

Erythropoietic Protoporphyria (EPP) | Small molecule | Rare Disease |BridgeBio Pharma, Inc.|Last Updated: Jul 29, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

PORT-77 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT06971900GATEWAY: A Phase 2a Study of PORT-77 in Adults With Erythropoietic ProtoporphyriaErythropoietic Protoporphyria (EPP)
COMPLETED28 Analytics
PHASE2COMPLETED
GATEWAY: A Phase 2a Study of PORT-77 in Adults With Erythropoietic Protoporphyria
Erythropoietic Protoporphyria (EPP)Unlock trial analytics

Study Endpoints

Primary Endpoints

Plasma PPIX level
9 Days

Change over the course of the study in plasma PPIX concentrations

Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
Day 21

Secondary Endpoints

Safety and tolerability
9 Days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last)
Day 1 through Day 9
Area Under the Plasma Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State (AUC0-12)
Up to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PORT-77EXPERIMENTALActive
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
PORT-77DRUGActive oral dose form
PlaceboDRUGMatching inactive oral dose form
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Major Inclusion Criteria: 1. BMI ≥18.0 and ≤40.0 kg/m2 and weight ≥50 kg on Day -1. 2. Nonsmoker or willing to refrain from the use of nicotine or tobacco-containing products for at least 30 days prior to the first dose of study drug based on participant self-reporting and agrees to refrain from th...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 29, 2026NCT06971900TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06971900TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06971900TRIAL_REMOVED: changed

Frequently asked questions about PORT-77

What is PORT-77 used for?

PORT-77 is an investigational small molecule being developed for erythropoietic protoporphyria (EPP), a rare disease. It has been studied in healthy adult participants and in adults with EPP. PORT-77 is not approved and remains in clinical development.

Who makes PORT-77?

PORT-77 is being developed by BridgeBio Pharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker BBIO. The company is conducting clinical trials of PORT-77 in the United States.

What phase is PORT-77 in?

PORT-77 is in Phase 2 clinical development for erythropoietic protoporphyria (EPP). It has completed a Phase 1 study in healthy participants and a Phase 2a study in adults with EPP. PORT-77 is investigational and not yet approved.

What clinical trials is PORT-77 in?

PORT-77 has been studied in two completed trials: NCT06346509, a Phase 1 single and multiple ascending dose study in healthy adults, and NCT06971900, the GATEWAY Phase 2a study in adults with erythropoietic protoporphyria. Both trials were conducted in the United States.

Is PORT-77 the same as any other drug?

No alternative names for PORT-77 have been disclosed. It is identified by the code name PORT-77 in clinical trial registrations and is being developed by BridgeBio Pharma.