Sovateltide_Dosage, benefits & legal status
Also known as Tyvalzi, Tycamzzi, IRL-1620, PMZ-1620, SPI-1620
Approved in India for ischaemic stroke on one sponsor-run trial of 158 people; results from the first test outside India are expected in 2028.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Sovateltide?
Plain language first. The technical label stays, but it never stands alone.Overview
It is meant to widen blood vessels around a stroke and help the brain repair itself over the following days. In a 158-person Indian trial, 22.7 percentage points more people were independent at 90 days than on saline. India approved it in May 2023; it is not approved anywhere else, and a trial of about 514 people in the US and Europe is under way.
Sovateltide (IRL-1620) is residues 8 to 21 of endothelin-1, a blood vessel hormone, rebuilt so it switches on the endothelin-B receptor about 120,000 times more selectively than the vessel-narrowing A receptor. Ciba-Geigy's Japanese labs made it in 1992; Pharmazz, founded by Anil Gulati, developed it for stroke, and Sun Pharma sells it in India as Tyvalzi.
What it's used for
A hospital injection for acute ischaemic stroke in India, given within 24 hours alongside standard care. Investigational everywhere else.
How does Sovateltide work?
What it does in the body, and where.Sovateltide switches on endothelin-B receptors, the relaxing half of a system whose A receptors tighten blood vessels.
- 01A selective switchEndothelin-1 normally hits both receptors. Swapping two cysteines and a lysine in its 8 to 21 fragment leaves a peptide that binds the B receptor at 0.016 nanomolar and the A receptor at 1,900.
- 02Blood flowIn animal studies, B-receptor activation widened brain vessels and raised blood flow to the area around a stroke, and fewer nerve cells there died.
- 03RepairThe developers propose that it promotes new nerve cells and vessels over days, their reason for dosing on days 1, 3 and 6. Human evidence for this mechanism is limited.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Indian phase 3
Clinical use- Human trial158 patients within 24 hours: independent at 90 days 22.67 points more often; mild deficit on the stroke scale (NIHSS 0 to 5) 85% against 68%.
- Human trialBarthel daily-living responders 76.1% against 63.4%, not significant (p=0.063).
- No dataSample size raised from 110 to 158 mid-trial; 16% against 10% dropped out; the control group got clot-dissolving drugs more often.
After approval
Clinical use- No dataA company-reported interim of the phase 4 gave 92% against 58% independent in 80 patients; the trial's primary endpoint is safety and the data are unpublished.
Outside India
Investigational- No dataRESPECT-ETB, about 514 people in the US and Europe, is the first independent test; topline results are expected in early 2028.
The 158-person phase 3 was the basis for the 2023 Indian approval, not a later confirmation; only its publication came afterwards. 'Patients were 22.7% more likely to recover (p=0.0045)' mixes two endpoints: 22.67 points is the absolute difference in independence, and p=0.0045 belongs to a different measure in completers. It was not positive on all three scales: the Barthel endpoint missed. 'No drug-related side effects' sits alongside 4 deaths against 2. The '92% success rate' is an interim look at a phase 4 whose main endpoint is safety. Hypovolaemic shock belongs to centhaquine, a different Pharmazz drug. Tyvalzi (Sun Pharma) and Tycamzzi (Pharmazz) are both brand names for it.
The published record
Papers and trials about Sovateltide
77 papers tagged human · 34 not reviews or lab · 3 clinical trial publications
11 registered trials · none with posted results
Furthest stage reached: Approved outside the US, India
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 401 papers and 11 trials indexed in detail.
At a glance
Four things to know about Sovateltide
Evidence
Clinical use
Category
Healing and recovery
Common vial
Varies
Half-life
About 4 to 8 minutes
How much, and do you cycle it?
The range, and whether you take breaks.0.3 mcg/kg, 3 doses a day on days 1, 3 and 6 (trial regimen), three doses 3 hours apart on days 1, 3 and 6. One course over 6 days Trial dose
Three injections on each of days 1, 3 and 6 after the stroke, then stop.
About 4 to 8 minutespeer-reviewed
The phase 2 paper gives 4.38 to 8.29 minutes, citing a rat study and the human phase 1 without saying which value came from which. The developers argue the effect on the receptor outlasts the drug in blood, hence repeat dosing on days 1, 3 and 6.
Source: Gulati A et al., CNS Drugs 2021 (introduction)
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Dosed by body weight in micrograms per kilogram. The calculator has no body-weight input, so it cannot produce a draw.
0.3 micrograms per kg as a 1-minute intravenous injection, three times 3 hours apart on day 1, repeated on days 3 and 6 (nine doses in all), starting within 24 hours of the stroke, on top of standard care. This is the regimen of every stroke trial and the Indian approval; the Indian label itself was not available to check. In healthy volunteers a single 0.9 mcg/kg dose was the minimum intolerable dose. Hospital-only; the vial calculator does not apply.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Sovateltide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 43% charged residues, 57% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Bleeding in the brain: it is only for ischaemic stroke confirmed on a scan
- More than 24 hours since the stroke began, outside the studied window
- People suitable for clot retrieval (thrombectomy) were excluded from the Indian phase 3, so there are no data alongside it
- Pregnancy, excluded from the trials
Stop and get help
- Fainting or a sudden fall in blood pressure
- New weakness, worsening speech, a severe headache or drowsiness, possible new bleeding
- Swelling of the face or throat, or trouble breathing
Common effects
- Any adverse event in 15 of 80 patients against 24 of 78 on saline in the phase 3
- Serious adverse events in 5 against 2, including 4 deaths against 2 at 90 days (not significant)
- Brain bleeding in 8.75% against 8.97%
- Four mild, short-lived side effects in 9 healthy volunteers at the highest dose
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Sovateltide approved?
And where the numbers on this page come from.Not in the United States. Sovateltide has no FDA approval. It is approved in India.
- Approval statusClinical use
- RouteInto a vein (1-minute injection), in hospital
- Checked13 October 2026
- Approved outside the USIndia: Approved by India's Central Drugs Standard Control Organisation on 31 May 2023 for cerebral ischaemic stroke, with a mandatory phase 4 trial; marketed by Sun Pharma as Tyvalzi. Not approved in the US.This does not change the United States position above.
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesGulati A et al., Drugs 2024;84:1637-1650 (Indian phase 3)Gulati A et al., CNS Drugs 2021;35:85-104 (Indian phase 2)CDSCO, list of new drugs approved in 2023CDSCO expert committee recommendation (Pharmatutor, 2022)FDA GSRS substance record, sovateltide (UNII 11X778QIZS)Takai M et al., Biochemical and Biophysical Research Communications 1992;184:953-959ClinicalTrials.gov, RESPECT-ETB (NCT05691244)ClinicalTrials.gov, SPI-1620 with docetaxel in lung cancer (NCT01741155)Pharmazz, $25 million investment from Sun Pharma (11 Jun 2025)Pharmazz and Sun Pharma licence for India (14 Sep 2023)Pharmazz, phase 4 enrolment complete (28 Sep 2026)Pharmazz, US orphan designation for neonatal HIE (14 Sep 2026)
What has happened recently
Approved by India's drug regulator on 31 May 2023 for cerebral ischaemic stroke (30 microgram injection), after an expert committee recommended it in 2022 on condition of a phase 4 trial, specialist-only prescribing and inspection of trial sites. Sun Pharma licensed Indian rights in September 2023 and has invested $40 million in Pharmazz. Not approved in the US, EU, UK or elsewhere. In the US, the RESPECT-ETB phase 3 (NCT05691244) has run since July 2025 under a special protocol assessment, the FDA granted orphan designation for neonatal hypoxic-ischaemic encephalopathy in September 2026, and a traumatic brain injury phase 3 was cleared the same month. Pharmazz says more than 140,000 Indian patients have been treated, an unaudited company figure. As SPI-1620, Spectrum Pharmaceuticals tested it in cancer before 2015.
You can compare this against the whole library, or read how to check a seller.
What else is like Sovateltide?
Others in Healing and recovery, side by side.If you're weighing Sovateltide, it's worth reading Thymosin Beta-15, BPC-157, and TB-500 / Thymosin Beta-4 in the same class.
Approved in India for ischaemic stroke on one sponsor-run trial of 158 people; results from the first test outside India are expected in 2028.
- Dose
- 0.3 mcg/kg, 3 doses a day on days 1, 3 and 6 (trial regimen)
- How often
- Three doses 3 hours apart on days 1, 3 and 6
A thymosin the research literature knows as a cancer marker, not a repair peptide.
- Dose
- Research only
- How often
- Not established
A popular healing peptide for injuries, gut, and joint or tendon pain.
- Dose
- 0.25 up to 0.5 mg per dose (start low, increase slowly)
- How often
- 1-2x daily
A recovery peptide for healing muscle and tendon, often paired with BPC-157.
- Dose
- 2 up to 2.5 mg per injection (start low, increase slowly)
- How often
- Twice a week
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Gulati A et al., Drugs 2024;84:1637-1650 (Indian phase 3)(2024)158 randomised within 24 hours: independent (mRS 0 to 2) at 90 days 22.67 points more often than saline, OR 2.75 (1.37 to 5.57). Barthel responder endpoint not significant (p=0.063). Deaths 4 against 2.
- Gulati A et al., CNS Drugs 2021;35:85-104 (Indian phase 2)(2021)40 patients, primary endpoint safety: no drug-related adverse events. Half-life given as 4.38 to 8.29 minutes.
- CDSCO, list of new drugs approved in 2023(2023)Sovateltide injection 30 micrograms approved 31 May 2023 for cerebral ischaemic stroke.
- CDSCO expert committee recommendation (Pharmatutor, 2022)(2022)Approval recommended on condition of a phase 4 trial, specialist prescribing and site inspections.
- FDA GSRS substance record, sovateltide (UNII 11X778QIZS)(2026)Sequence DEEAVYFAHLDIIW with an N-succinyl aspartate; CAS 142569-99-1; MW about 1821.
- Takai M et al., Biochemical and Biophysical Research Communications 1992;184:953-959(1992)IRL 1620 designed at Ciba-Geigy Japan as a selective endothelin-B agonist: Suc-[Glu9,Ala11,15]-endothelin-1(8-21).
- ClinicalTrials.gov, RESPECT-ETB (NCT05691244)(2026)Phase 3 in the US, Germany, Spain and the UK, about 514 people, recruiting since July 2025.
- ClinicalTrials.gov, SPI-1620 with docetaxel in lung cancer (NCT01741155)(2015)Terminated: did not meet its efficacy endpoint; 34 enrolled.
- Pharmazz, $25 million investment from Sun Pharma (11 Jun 2025)(2025)FDA agreed the RESPECT-ETB design under a special protocol assessment; Sun Pharma's total commitment reaches $40 million; brand names Tycamzzi and Tyvalzi.
- Pharmazz and Sun Pharma licence for India (14 Sep 2023)(2023)Licence for Sun Pharma to commercialise sovateltide in India as Tyvalzi.
- Pharmazz, phase 4 enrolment complete (28 Sep 2026)(2026)160-patient phase 4 with safety as the primary endpoint; company-reported interim efficacy; more than 140,000 patients treated in India.
- Pharmazz, US orphan designation for neonatal HIE (14 Sep 2026)(2026)Orphan drug designation for neonatal hypoxic-ischaemic encephalopathy.
Beyond these, 412 records are indexed. Browse the records