SIM0417

Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 2 active Small molecule

SIM0417 is a Small molecule drug developed by Jiangsu Simcere Pharmaceutical Co., Ltd.. It is currently in Phase 2 development. Also known as: Simnotrelvir.

SIM0417, also known as SSD8432, is being studied in clinical trials for COVID-19, atopic dermatitis, and elderly conditions. The trials are evaluating the efficacy of SSD8432 in different doses, including 300mg and 750mg, in combination with ritonavir for COVID-19.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	SIM0417
Also known as	Simnotrelvir
Sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• To Evaluate SSD8432/ Ritonavir in Adults With COVID-19 (PHASE1, PHASE2)
• A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19 (PHASE2, PHASE3)
• Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects (PHASE1)
• Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir (PHASE1)
• Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants (PHASE1)
• Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants (PHASE1)
• Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study (PHASE2)
• To Evaluate SSD8432/Ritonavir in Adults With COVID-19 (PHASE2, PHASE3)

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:

• SIM0417 CI brief — competitive landscape report
• SIM0417 updates RSS · CI watch RSS
• Jiangsu Simcere Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about SIM0417

What is SIM0417?

SIM0417 is a Small molecule drug developed by Jiangsu Simcere Pharmaceutical Co., Ltd..

Who makes SIM0417?

SIM0417 is developed by Jiangsu Simcere Pharmaceutical Co., Ltd. (see full Jiangsu Simcere Pharmaceutical Co., Ltd. pipeline at /company/jiangsu-simcere-pharmaceutical-co-ltd).

Is SIM0417 also known as anything else?

SIM0417 is also known as Simnotrelvir.

What development phase is SIM0417 in?

SIM0417 is in Phase 2.

Related

• Manufacturer: Jiangsu Simcere Pharmaceutical Co., Ltd. — full pipeline
• Also known as: Simnotrelvir