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RZL-012
RZL-012 is a Small molecule drug developed by Raziel Therapeutics Ltd.. It is currently in Phase 2 development.
RZL-012 is a small molecule intervention being studied for the treatment of Submental Fat, Dercum's Disease Lipomas, Lipedema, and Dercum Disease. It is being investigated in an open-label Phase 2 study to compare its pharmacokinetics and efficacy in Chinese versus non-Chinese subjects.
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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).
| 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 | RZL-012 |
|---|---|
| Sponsor | Raziel Therapeutics Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease (PHASE2)
- RZL-012 for Dercum's Disease Lipomas (PHASE2)
- Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events (PHASE1, PHASE2)
- An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects. (PHASE1, PHASE2)
- An Open-label Study That Will Test a Second Treatment Session of RZL-012. (PHASE2)
- Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks (PHASE2)
- A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers. (PHASE2)
- Efficacy and Safety of RZL-012 on Submental Fat Reduction (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:
- RZL-012 CI brief — competitive landscape report
- RZL-012 updates RSS · CI watch RSS
- Raziel Therapeutics Ltd. portfolio CI
Frequently asked questions about RZL-012
What is RZL-012?
Who makes RZL-012?
What development phase is RZL-012 in?
Related
- Manufacturer: Raziel Therapeutics Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing