Last reviewed 2026-05-28 · How we verify

Sofodelevier

Genuine Research Center, Egypt · Phase 1 active Small molecule ✓ Verified May 2026

Sofodelevier is a Small molecule drug developed by Genuine Research Center, Egypt. It is currently in Phase 1 development. Also known as: Sovaldi.

Sofodelevier is a 400 mg film-coated tablet used in a bio-equivalence study to compare its effects with Sovaldi 400 mg tablets. The study, conducted by the Genuine Research Center in Egypt, involved healthy participants and examined the bio-equivalence of Sofodelevier to Sovaldi.

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	Sofodelevier
Also known as	Sovaldi
Sponsor	Genuine Research Center, Egypt
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada) (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:

Sofodelevier CI brief — competitive landscape report
Sofodelevier updates RSS · CI watch RSS
Genuine Research Center, Egypt portfolio CI

Frequently asked questions about Sofodelevier

What is Sofodelevier?

Sofodelevier is a Small molecule drug developed by Genuine Research Center, Egypt.

Who makes Sofodelevier?

Sofodelevier is developed by Genuine Research Center, Egypt (see full Genuine Research Center, Egypt pipeline at /company/genuine-research-center-egypt).

Is Sofodelevier also known as anything else?

Sofodelevier is also known as Sovaldi.

What development phase is Sofodelevier in?

Sofodelevier is in Phase 1.

Manufacturer: Genuine Research Center, Egypt — full pipeline
Therapeutic area: All drugs in Other
Also known as: Sovaldi

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