FDA · United States
calcium — FDA regulatory status
calcium (CAL-500) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- CAL-500
- Originator
- Lacuna Pharma Pty Ltd
- Structured fields
- 6
Sponsor / originator context: Lacuna Pharma Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 95 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 20210081 | Phase 3 | Amgen | 2022-502352-31-00 |
| A021502 | Phase 3 | George Institute for | 2024-517269-18-00 |
| APHP200073 | Phase 3 | PARItec | 2024-516018-39-00 |
| APHP211429 | Phase 3 | PARItec | 2024-514610-13-00 |
| APHP220917 | Phase 3 | PARItec | 2023-504831-42-00 |
| AZP-3601-CLI-002 | Phase 3 | Alexion Europe SAS | 2022-503126-12-01 |
| C3651021 | Phase 3 | First Biotech (Australia) | 2025-522093-36-00 |
| C4221015 | Phase 3 | First Biotech (Australia) | 2023-509405-77-00 |
| C6461003 | Phase 3 | First Biotech (Australia) | 2025-523521-18-00 |
| CA2660003 | Phase 3 | Bristol-Myers Squibb Australia | 2025-523224-45-00 |
| CA2660004 | Phase 3 | Bristol-Myers Squibb Australia | 2025-523263-37-00 |
| COLCHICINE OPOCALCIUM 1 mg, comprimé sécable | Phase 3 | PARItec | 2024-513669-38-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026082899 | ARN POUR LA PREVENTION OU LE TRAITEMENT DE LA TUBERCULOSE | WO |
| 2026068864 | DOMAINES CH1 ET CL MODIFIÉS POUR LA PRÉVENTION DU MÉSAPPARIEMENT DE CHAÎNE | WO |
| 2026062193 | COMPOSITIONS ET PROCÉDÉS | WO |
| 2026057626 | PEPTIDOGLYCANE HYDROLASES AYANT DE MULTIPLES DOMAINES ENZYMATIQUEMENT ACTIFS | WO |
| 2026057625 | PEPTIDOGLYCANE HYDROLASES AYANT UN DOMAINE CHAP AVEC SITE ACTIF MODIFIÉ | WO |
| 2026058153 | UTILISATIONS DE RÉCEPTEUR DE LYMPHOCYTES T DE VPH-16 ET COMPOSITIONS ASSOCIÉES | WO |
| 2026047601 | RÉCEPTEURS DE LYMPHOCYTES T (TCR) | WO |
| 2026033380 | PROCESSUS DE PRÉPARATION DE COMPLEXES OLIGOSACCHARIDIQUES | WO |
| 2026027695 | COMPOSITIONS ET PROCÉDÉS | WO |
| 2026021698 | PARTICULE D'ACIDE NUCLÉIQUE | WO |
| 2026015857 | COMPOSITION DE VACCIN DESTINÉE À DÉCLENCHER UNE RÉPONSE DES LYMPHOCYTES T CD8+ SPÉCIFIQUE DE L'EBV | WO |
| 2026013643 | PROCÉDÉS ET COMPOSITIONS POUR CONCEVOIR DES CHAÎNES D'ÉPITOPES AVEC DES LIEURS | WO |
Related hubs
FAQ
What is the FDA approval status of calcium?
calcium currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get calcium regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to calcium?
This spoke lists 95 published programs associated with calcium in our pipeline index.