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A 14-residue fragment of endothelin-1 that activates only the ETB receptor — approved in India for stroke, and not yet anywhere else.
Also known as: IRL-1620 · PMZ-1620 · SPI-1620 · Tycamzzi
Part of the Neuropeptides & signaling cluster
Overview
Sovateltide (Tycamzzi, IRL-1620) is a synthetic 14-amino-acid analogue of endothelin-1 residues 8–21 that acts as a highly selective endothelin-B receptor agonist. Proposed to increase cerebral blood flow and promote neuronal differentiation after ischaemia, it was approved in India in May 2023 for acute cerebral ischaemic stroke within 24 hours of onset, after a phase 3 trial in which 22.67% more patients reached a good functional outcome at 90 days. It is not approved in North America or Europe.
Source & context
Biological / chemical source: Synthetic analogue of endothelin-1 residues 8–21 (Pharmazz)
Primary research or clinical context: Approved (India CDSCO, May 2023) for acute cerebral ischaemic stroke within 24 hours of onset; investigational in hypoxic-ischaemic encephalopathy and spinal cord injury; not approved by the FDA, EMA or Health Canada
What sovateltide is
Sovateltide is a synthetic 14-residue peptide derived from endothelin-1, the potent vasoconstrictor peptide. Where endothelin-1 acts on both ETA and ETB receptors, sovateltide — previously known as IRL-1620 and PMZ-1620 — is a highly selective ETB agonist. Developed by Pharmazz as a “neural progenitor cell therapeutic” for stroke, hypoxic-ischaemic encephalopathy, spinal cord injury and Alzheimer's disease, it was approved by India's Central Drugs Standard Control Organization in May 2023, as Tycamzzi, for acute cerebral ischaemic stroke treated within 24 hours of onset (Keam, Drugs 2023). No approval in North America or Europe appears in the evidence for this profile.
Sequence and structure
The IUPHAR one-letter sequence is DEEAVYFAHLDIIW, displayed as chips above. PubChem records the full designation as succinyl-[Glu9,Ala11,Ala15]-endothelin-1(8–21): the C-terminal 14 residues of endothelin-1 with three substitutions and a succinyl group capping the N-terminus. Removing endothelin's N-terminal disulfide-bonded loop and altering these positions abolishes ETA activity while preserving ETB binding. The molecular formula, C86H117N17O27, and mass of about 1,821 Da are from the PubChem record.
Proposed mechanism
ETB receptors in the brain are expressed on neural progenitor cells and vascular endothelium. In rats, sovateltide given intravenously after ischaemic stroke increased cerebral blood flow, had anti-apoptotic activity and produced neurovascular remodelling (Gulati et al., CNS Drugs 2021). Follow-up work reported activation of neuronal differentiation and prevention of mitochondrial dysfunction in adult mammalian brain after stroke, with cerebral ETB receptors identified as the mediator (Ranjan et al., Scientific Reports 2020). In a rat spinal cord injury model it improved motor function and reduced hyperalgesia (Mavridis et al., Neurocritical Care 2024).
Phase 2 safety trial
A prospective, multicentre, randomised, double-blind, placebo-controlled study in India enrolled adults aged 18–70 with radiologically confirmed ischaemic stroke within 24 hours, excluding intracranial haemorrhage and endovascular therapy. Sovateltide was given as three intravenous boluses of 0.3 μg/kg on days 1, 3 and 6 in addition to standard of care, with safety as the primary objective and NIHSS, modified Rankin Scale and Barthel Index as efficacy measures (Gulati et al., CNS Drugs 2021). Safety and tolerability had first been confirmed in healthy volunteers.
Phase 3 trial
The phase 3 trial randomised 158 patients (80 sovateltide, 78 control) with acute ischaemic stroke and NIHSS of 6 or more, treated about 18 hours after onset on top of standard care. At day 90 the proportion with a modified Rankin Scale score of 0–2 was 22.67 percentage points higher with sovateltide (odds ratio 2.75, 95% CI 1.37–5.57), the proportion with NIHSS 0–5 was 17.05 points higher (OR 2.67), and an improvement of at least 2 mRS points occurred in 72.50% versus 51.28% (OR 2.50). Intracranial haemorrhage occurred in 8.75% and 8.97% respectively, and adverse events were judged unrelated to the drug (Gulati et al., Drugs 2024).
| Endpoint | Sovateltide (n = 80) | Control (n = 78) | Odds ratio (95% CI) |
|---|---|---|---|
| mRS 0–2 | +22.67 percentage points | reference | 2.75 (1.37–5.57) |
| NIHSS 0–5 | +17.05 percentage points | reference | 2.67 (1.27–5.90) |
| ≥ 2-point mRS improvement | 72.50% | 51.28% | 2.50 (1.29–4.81) |
| Intracranial haemorrhage | 8.75% | 8.97% | — |
Status and ongoing trials as of September 2026
ClinicalTrials.gov lists a recruiting phase 3 stroke trial, a phase 4 study, phase 2 trials in hypoxic-ischaemic encephalopathy and acute spinal cord injury, and a completed phase 2 stroke study. The evidence base is notable for coming largely from the developer's own group and from trials conducted in India; independent confirmation outside that setting had not been published in the evidence for this profile. Sovateltide is a hospital-administered intravenous drug; nothing here is guidance on its use.
Relation to other peptides on this site
Endothelin-1 itself is profiled on this site as a vasoactive hormone; sovateltide shows how a fragment with selected substitutions can flip a peptide's therapeutic logic from vasoconstriction to repair signalling. It sits in the neuro cluster alongside semax, selank and cerebrolysin-type peptides — but unlike them it has a randomised phase 3 trial and a national approval behind it.
Sequence of the selected reference form
Sequence backbone for the reference form: Sovateltide (IRL-1620), N-succinyl free peptide. Termini, stereochemistry and modifications are described below.
Structure & chemistry
Molecular identity & reference confidence
Source-supported reference
The original1992 synthesis paper names the N-alpha-succinyl analogue and its substitutions. GSRS explicitly defines the14-residue sequence and N-succinyl Asp1. PubChem16130933 and16133819 have exactly identical full standard InChI; their imidazole naming variation is not a molecular-form disagreement. This estimated attribute differs from the explicit N-succinyl chemical structure and is not used. PubChemC86H117N17O27 matches independent atom accounting. GSRS rounded sequence mass1821 is treated only as approximate, not substituted for1820.9.
- Molecular form
- Sovateltide (IRL-1620), N-succinyl free peptide
- Species
- Synthetic endothelin-1 analogue; not a natural species-specific peptide
- Termini (N / C)
- N-succinyl-Asp / Trp free carboxylic acid
Average reference mass · Molecular identity assessment: 2026-10-05
Reference policy updated: 2026-10-05
- PubChem PUG molecular properties, CID 16130933 · 2026-10-05
- PubChem structure-derived biologic notation, CID 16130933 · 2026-10-05
- NIH NCATS/FDA GSRS, UNII 11X778QIZS · 2026-10-05
- Original IRL-1620 synthesis and receptor study (1992) · 2026-10-05
Suc-Asp-Glu-Glu-Ala-Val-Tyr-Phe-Ala-His-Leu-Asp-Ile-Ile-Trp-OH
- Molecular formula
- C86H117N17O27
- Average reference mass
- ≈ 1,820.9
- Receptors
- Endothelin-B receptor (ETB), selective over ETA
- Backbone
- Sovateltide (IRL-1620), N-succinyl free peptide
- C-terminus
- Trp free carboxylic acid
- Status
- Approved: India CDSCO, May 2023 (acute cerebral ischaemic stroke). Phase 3 recruiting elsewhere; not approved by FDA, EMA or Health Canada as of September 2026
- PubChem CID: 16130933
- CAS RN: 142569-99-1
- UNII: 11X778QIZS
Chemistry values: curated profile, PubChem.
Clinical development snapshot
ClinicalTrials.gov lists 10 registered studies with “Sovateltide” as an intervention (snapshot 2026-10-01). A registry footprint is not evidence of efficacy or approval.
| NCT | Title | Phase | Status | Updated |
|---|---|---|---|---|
| NCT05955326 | Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | Phase 4 | active not recruiting | 2026-09-29 |
| NCT05691244 | Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | Phase 3 | recruiting | 2026-09-15 |
| NCT05514340 | Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy | Phase 2 | recruiting | 2025-12-31 |
| NCT04054414 | PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury | Phase 2 | recruiting | 2025-07-04 |
| NCT04046484 | PMZ-1620 (Sovateltide) in Acute Ischemic Stroke Patients | Phase 2 | completed | 2025-05-12 |
| NCT04047563 | Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke | Phase 3 | completed | 2023-10-18 |
Sovateltide — reconstitution calculator
Enter how much peptide is in the vial and how much diluent (e.g. bacteriostatic water) is added. The tool returns the resulting solution concentration — and, for any amount you type, the volume it corresponds to. This is educational arithmetic, not a dosing recommendation.
Reference form: Sovateltide (IRL-1620), N-succinyl free peptideAverage reference mass: 1,820.9 Da
Enter an amount to see the volume it corresponds to.
Educational concentration mathematics only. This tool does not recommend a dose, amount, or protocol, and nothing here is medical advice. Many peptides are not authorized by Health Canada for human use — see our reconstitution and bacteriostatic-water guides for context.
Change log
Dated observations from the data pipeline (registry flags, trial footprints, identifiers) and editorial reviews of this profile.
- IdentifiersCross-linked to IUPHAR ligand 3886 and PubChem CID 16133819.
- TrialsClinicalTrials.gov snapshot added: 10 registered studies, highest phase 4.
- EditorialProfile content reviewed and updated by the editorial team.
FAQ about Sovateltide
What is Sovateltide?+
Sovateltide (Tycamzzi, IRL-1620) is a synthetic 14-amino-acid analogue of endothelin-1 residues 8–21 that acts as a highly selective endothelin-B receptor agonist. Proposed to increase cerebral blood flow and promote neuronal differentiation after ischaemia, it was approved in India in May 2023 for acute cerebral ischaemic stroke within 24 hours of onset, after a phase 3 trial in which 22.67% more patients reached a good functional outcome at 90 days. It is not approved in North America or Europe.
What Canadian product status is recorded for Sovateltide?+
Canadian product status for Sovateltide has not been verified in this profile. No verified record here does not mean no authorization exists. Status depends on the product, formulation and use; consult Health Canada's product records.
What is the length of the selected reference form for Sovateltide?+
The selected reference form (Sovateltide (IRL-1620), N-succinyl free peptide) has 14 residues or residue-derived units in its backbone. Other forms in this family may have a different length.
What is sovateltide?+
A synthetic 14-amino-acid endothelin-1 fragment analogue (Tycamzzi, IRL-1620) that selectively activates the endothelin-B receptor. Approved in India in May 2023 for acute ischaemic stroke within 24 hours.
Is sovateltide approved in the US, Canada or Europe?+
No. Its only approval documented here is India's CDSCO (May 2023). A phase 3 trial is recruiting as of September 2026.
How does sovateltide work?+
By activating ETB receptors on neural progenitor cells and blood vessels, which in animal studies increased cerebral blood flow, reduced apoptosis and promoted neuronal differentiation after stroke.
What did the phase 3 trial show?+
At 90 days, 22.67 percentage points more patients reached mRS 0–2 with sovateltide (odds ratio 2.75), with intracranial haemorrhage rates similar to control (8.75% vs 8.97%).
What is the sequence of sovateltide?+
DEEAVYFAHLDIIW — endothelin-1 residues 8–21 with Glu9, Ala11 and Ala15 substitutions and an N-terminal succinyl group.
Related peptides
References & further reading
- 1.Gulati A et al. (2024). Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase III Clinical Trial. Drugs
- 2.Keam SJ (2023). Sovateltide: First Approval. Drugs
- 3.Gulati A et al. (2021). Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs
- 4.Ranjan AK et al. (2020). Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke. Scientific Reports
- 5.Mavridis T et al. (2024). Sovateltide Improves Motor Function and Reduces Hyperalgesia in a Rat Model of Spinal Cord Injury. Neurocritical Care
- 6.PubChem — Sovateltide (CID 16133819)