Brazilian researchers at UFRJ, together with pharmaceutical lab Cristália, have thrust polylaminin (a polymerized form of laminin derived from human placenta) into the national spotlight after showcasing patients with spinal-cord injuries who regained movement during experimental use. Major outlets covered the announcement this week (Setember 2025), while emphasizing that the therapy is not yet approved and that regulators are still reviewing data. Cristália says it has product ready for broader clinical evaluation as soon as regulators give the nod.
Anvisa’s position—reported in national media—is that a formal Phase 1 request has not yet been approved and that the agency still awaits complementary preclinical information before advancing.
Meanwhile, academic signals range from a 2010 rat study showing axonal regrowth and early locomotor recovery, to a 2024 human preprint in acute complete SCI, and a 2025 veterinary study in dogs with chronic SCI suggesting safety and modest gait gains.
The path from here to a marketing registro typically spans multiple trial phases and manufacturing/quality reviews; hence the open question: will approval arrive before 2028?
How this market resolves (summary):
- YES if Anvisa issues a marketing authorization (registro sanitário) for any polylaminin-based medicine (any brand/indication) on or before Dec 31, 2027 (23:59:59 BRT).
- NO otherwise.
- Clinical-trial authorizations, expanded access, named-patient use, or manufacturing for research do not count.
Further reading / sources:
- CNN Brasil explainer on the announcement and regulatory status: https://www.cnnbrasil.com.br/saude/medicamento-inedito-devolve-movimento-a-pacientes-com-lesao-na-medula/
- VEJA report quoting Anvisa’s stance on pending data and lack of formal Phase 1 approval: https://veja.abril.com.br/saude/medicamento-experimental-brasileiro-devolve-mobilidade-a-pessoas-com-tetraplegia/
- UFRJ institutional note on the project and pending Anvisa authorization: https://prefeitura.ufrj.br/2025/09/pesquisadora-da-ufrj-desenvolve-medicamento-promissor-para-reversao-de-lesao-medular/
- Cristália press release on readiness and waiting for Phase 1 go-ahead: https://www.cristalia.com.br/releases/laboratorio-cristalia-inicia-producao-de-medicamento-inedito-no-mundo-que-devolve-movimento-a-pacientes-com-lesao-na-medula
- medRxiv pilot human preprint (acute complete SCI): https://www.medrxiv.org/content/10.1101/2024.02.19.24301010v1
- PubMed (rats, 2010): https://pubmed.ncbi.nlm.nih.gov/20643907/
- PubMed (dogs, 2025): https://pubmed.ncbi.nlm.nih.gov/40881640/
- Brazilian trial registry (REBEC) entry: https://ensaiosclinicos.gov.br/rg/RBR-9dfvgpm
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