Last reviewed 2026-05-29 · How we verify

SCY-078 plus PRA

Scynexis, Inc. · Phase 1 active Small molecule ✓ Verified May 2026

SCY-078 plus PRA is a Small molecule drug developed by Scynexis, Inc.. It is currently in Phase 1 development.

SCY-078, also known as ibrexafungerp, is being studied in combination with pravastatin (PRA) to evaluate its effect on the pharmacokinetics of pravastatin in healthy subjects. This study, NCT04092751, is an open-label, randomized, two-period crossover study conducted by Scynexis, Inc.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	SCY-078 plus PRA
Sponsor	Scynexis, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

SCY-078 plus PRA CI brief — competitive landscape report
SCY-078 plus PRA updates RSS · CI watch RSS
Scynexis, Inc. portfolio CI

Frequently asked questions about SCY-078 plus PRA

What is SCY-078 plus PRA?

SCY-078 plus PRA is a Small molecule drug developed by Scynexis, Inc..

Who makes SCY-078 plus PRA?

SCY-078 plus PRA is developed by Scynexis, Inc. (see full Scynexis, Inc. pipeline at /company/scynexis-inc).

What development phase is SCY-078 plus PRA in?

SCY-078 plus PRA is in Phase 1.

Manufacturer: Scynexis, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing