Last reviewed 2026-05-21 · How we verify

SEL-212 high-dose

Swedish Orphan Biovitrum · Phase 3 active Small molecule ✓ Verified May 2026

SEL-212 high-dose is a Uricase with immunosuppressant combination Small molecule drug developed by Swedish Orphan Biovitrum. It is currently in Phase 3 development for Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy).

SEL-212 is a combination therapy that pairs a uricase enzyme with an immunosuppressant to lower uric acid levels while preventing immune reactions against the enzyme.

SEL-212 is a small molecule being studied for the treatment of conditions such as gout, chronic gout, and hyperuricemia. It is administered in combination with SEL-110 as part of a Phase I clinical trial to assess its safety and pharmacodynamics.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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 name	SEL-212 high-dose
Sponsor	Swedish Orphan Biovitrum
Drug class	Uricase with immunosuppressant combination
Target	Uric acid (via pegsiticase uricase enzyme)
Modality	Small molecule
Therapeutic area	Rheumatology / Gout
Phase	Phase 3

Mechanism of action

SEL-212 combines pegsiticase (a recombinant uricase that breaks down uric acid into allantoin) with methotrexate as an immunosuppressant. The methotrexate component is designed to prevent the formation of anti-drug antibodies that typically develop against pegsiticase, allowing sustained uric acid reduction in patients with severe gout who are refractory to conventional therapies.

Approved indications

Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy)

Common side effects

Infusion reactions
Gout flares
Methotrexate-related toxicity (hepatotoxicity, myelosuppression)
Anti-drug antibody formation

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.

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:

SEL-212 high-dose CI brief — competitive landscape report
SEL-212 high-dose updates RSS · CI watch RSS
Swedish Orphan Biovitrum portfolio CI

Frequently asked questions about SEL-212 high-dose

What is SEL-212 high-dose?

SEL-212 high-dose is a Uricase with immunosuppressant combination drug developed by Swedish Orphan Biovitrum, indicated for Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy).

How does SEL-212 high-dose work?

SEL-212 is a combination therapy that pairs a uricase enzyme with an immunosuppressant to lower uric acid levels while preventing immune reactions against the enzyme.

What is SEL-212 high-dose used for?

SEL-212 high-dose is indicated for Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy).

Who makes SEL-212 high-dose?

SEL-212 high-dose is developed by Swedish Orphan Biovitrum (see full Swedish Orphan Biovitrum pipeline at /company/swedish-orphan-biovitrum).

What drug class is SEL-212 high-dose in?

SEL-212 high-dose belongs to the Uricase with immunosuppressant combination class. See all Uricase with immunosuppressant combination drugs at /class/uricase-with-immunosuppressant-combination.

What development phase is SEL-212 high-dose in?

SEL-212 high-dose is in Phase 3.

What are the side effects of SEL-212 high-dose?

Common side effects of SEL-212 high-dose include Infusion reactions, Gout flares, Methotrexate-related toxicity (hepatotoxicity, myelosuppression), Anti-drug antibody formation.

What does SEL-212 high-dose target?

SEL-212 high-dose targets Uric acid (via pegsiticase uricase enzyme) and is a Uricase with immunosuppressant combination.

Drug class: All Uricase with immunosuppressant combination drugs
Target: All drugs targeting Uric acid (via pegsiticase uricase enzyme)
Manufacturer: Swedish Orphan Biovitrum — full pipeline
Therapeutic area: All drugs in Rheumatology / Gout
Indication: Drugs for Refractory gout (severe, uncontrolled hyperuricemia in patients inadequately responsive to conventional urate-lowering therapy)

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