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supportive and immunosuppressive therapy
supportive and immunosuppressive therapy is a Immunosuppressant Small molecule drug developed by RWTH Aachen University. It is currently in Phase 3 development for Prevention of organ rejection in transplant patients.
Supportive and immunosuppressive therapy involves the use of medications to suppress the immune system and prevent rejection in organ transplant patients, while also providing supportive care to manage symptoms and improve quality of life.
Supportive therapy is used to treat various conditions, including Multiple Myeloma, Renal Transplantation, Systemic Lupus Erythematosus, Sepsis, and Immune Dysfunction, as indicated by ClinicalTrials.gov. Immunomodulatory small molecules, such as Lenalidomide, are used in supportive therapy, as classified by ChEMBL, to modulate the immune system and treat these conditions.
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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.
| 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 | supportive and immunosuppressive therapy |
|---|---|
| Sponsor | RWTH Aachen University |
| Drug class | Immunosuppressant |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This type of therapy typically involves a combination of immunosuppressive medications, such as corticosteroids and calcineurin inhibitors, which work to reduce the activity of the immune system and prevent it from attacking the transplanted organ. Supportive care may include medications to manage symptoms such as pain, nausea, and fatigue, as well as treatments to prevent infections and other complications.
Approved indications
- Prevention of organ rejection in transplant patients
Common side effects
- Infections
- Nausea
- Vomiting
- Diarrhea
- Fatigue
Key clinical trials
- US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies (PHASE1, PHASE2)
- The Anifrolumab PRIM Program
- Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM (NA)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
- Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PHASE4)
- Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases (PHASE2)
- Saphnelo Use in Females of Child-bearing Potential
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:
- supportive and immunosuppressive therapy CI brief — competitive landscape report
- supportive and immunosuppressive therapy updates RSS · CI watch RSS
- RWTH Aachen University portfolio CI
Frequently asked questions about supportive and immunosuppressive therapy
What is supportive and immunosuppressive therapy?
How does supportive and immunosuppressive therapy work?
What is supportive and immunosuppressive therapy used for?
Who makes supportive and immunosuppressive therapy?
What drug class is supportive and immunosuppressive therapy in?
What development phase is supportive and immunosuppressive therapy in?
What are the side effects of supportive and immunosuppressive therapy?
Related
- Drug class: All Immunosuppressant drugs
- Manufacturer: RWTH Aachen University — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of organ rejection in transplant patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing