MSL-109

Johns Hopkins Bloomberg School of Public Health · Phase 2 active Small molecule

MSL-109 is a Small molecule drug developed by Johns Hopkins Bloomberg School of Public Health. It is currently in Phase 2 development. Also known as: Monoclonal antibodies.

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	MSL-109
Also known as	Monoclonal antibodies
Sponsor	Johns Hopkins Bloomberg School of Public Health
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS (PHASE2)
• Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT) (PHASE2, PHASE3)
• A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT) (PHASE2)
• A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria (PHASE1)
• Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease (PHASE1, PHASE2)
• A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis (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:

• MSL-109 CI brief — competitive landscape report
• MSL-109 updates RSS · CI watch RSS
• Johns Hopkins Bloomberg School of Public Health portfolio CI

Frequently asked questions about MSL-109

What is MSL-109?

MSL-109 is a Small molecule drug developed by Johns Hopkins Bloomberg School of Public Health.

Who makes MSL-109?

MSL-109 is developed by Johns Hopkins Bloomberg School of Public Health (see full Johns Hopkins Bloomberg School of Public Health pipeline at /company/johns-hopkins-bloomberg-school-of-public-health).

Is MSL-109 also known as anything else?

MSL-109 is also known as Monoclonal antibodies.

What development phase is MSL-109 in?

MSL-109 is in Phase 2.

Related

• Manufacturer: Johns Hopkins Bloomberg School of Public Health — full pipeline
• Also known as: Monoclonal antibodies