TCD601

ITB-Med LLC · Phase 2 active Biologic

TCD601 is a Biologic drug developed by ITB-Med LLC. It is currently in Phase 2 development. Also known as: Siplizumab, siplizumab.

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	TCD601
Also known as	Siplizumab, siplizumab
Sponsor	ITB-Med LLC
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (PHASE1)
• A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation (PHASE2)
• Siplizumab for Sickle Cell Disease Transplant (PHASE1, PHASE2)
• Siplizumab in T1DM (PHASE1, PHASE2)
• A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE) (PHASE2)
• A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA) (PHASE2)
• A Study of TCD601 in de Novo Renal Transplant Recipients (PHASE2)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (PHASE2)

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:

• TCD601 CI brief — competitive landscape report
• TCD601 updates RSS · CI watch RSS
• ITB-Med LLC portfolio CI

Frequently asked questions about TCD601

What is TCD601?

TCD601 is a Biologic drug developed by ITB-Med LLC.

Who makes TCD601?

TCD601 is developed by ITB-Med LLC (see full ITB-Med LLC pipeline at /company/itb-med-llc).

Is TCD601 also known as anything else?

TCD601 is also known as Siplizumab, siplizumab.

What development phase is TCD601 in?

TCD601 is in Phase 2.

Related

• Manufacturer: ITB-Med LLC — full pipeline
• Also known as: Siplizumab, siplizumab