Last reviewed · How we verify

RO0503821 (1x/2 Weeks)

Hoffmann-La Roche · Phase 3 active Small molecule Under review

RO0503821 (1x/2 Weeks) is a Bispecific antibody Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Solid tumors or hematologic malignancies (specific indication not publicly disclosed). Also known as: Mircera.

RO0503821 is a bispecific antibody that simultaneously engages two distinct molecular targets to enhance immune activation and tumor cell killing.

RO0503821 is a medication being studied in clinical trials for the treatment of anemia in patients with chronic kidney disease not yet on dialysis. It is administered either once or twice a week in subcutaneous injections as part of a study comparing its efficacy and safety to other treatments, including Mircera and Epoetin alfa or beta.

Likelihood of approval
64.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
  • Big-pharma sponsor +3.0pp
    Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameRO0503821 (1x/2 Weeks)
Also known asMircera
SponsorHoffmann-La Roche
Drug classBispecific antibody
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

As a bispecific antibody candidate from Roche, RO0503821 is designed to bridge immune effector cells with tumor cells or other disease-relevant targets, potentially enhancing T-cell activation and cytotoxic activity. The exact dual targets remain proprietary, but the bispecific format allows simultaneous engagement of two epitopes or receptors, which may overcome resistance mechanisms seen with monospecific approaches. The twice-weekly dosing schedule suggests a molecule with favorable pharmacokinetics suitable for maintenance therapy.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about RO0503821 (1x/2 Weeks)

What is RO0503821 (1x/2 Weeks)?

RO0503821 (1x/2 Weeks) is a Bispecific antibody drug developed by Hoffmann-La Roche, indicated for Solid tumors or hematologic malignancies (specific indication not publicly disclosed).

How does RO0503821 (1x/2 Weeks) work?

RO0503821 is a bispecific antibody that simultaneously engages two distinct molecular targets to enhance immune activation and tumor cell killing.

What is RO0503821 (1x/2 Weeks) used for?

RO0503821 (1x/2 Weeks) is indicated for Solid tumors or hematologic malignancies (specific indication not publicly disclosed).

Who makes RO0503821 (1x/2 Weeks)?

RO0503821 (1x/2 Weeks) is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

Is RO0503821 (1x/2 Weeks) also known as anything else?

RO0503821 (1x/2 Weeks) is also known as Mircera.

What drug class is RO0503821 (1x/2 Weeks) in?

RO0503821 (1x/2 Weeks) belongs to the Bispecific antibody class. See all Bispecific antibody drugs at /class/bispecific-antibody.

What development phase is RO0503821 (1x/2 Weeks) in?

RO0503821 (1x/2 Weeks) is in Phase 3.

Related

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